{
    "info": {
        "nct_id": "NCT05286294",
        "official_title": "MITRIC: Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clincal Responders",
        "inclusion_criteria": "1. Participant must be 18 years of age, at the time of signing the informed consent\n2. Histologically confirmed malignant melanoma, NSCLC, CSCC, HNSCC, renal clear cell carcinoma or MSI+ solid cancer\n3. Metastatic disease or local recurrence not curable by standard therapy\n4. PD-L1 positivity is required for subjects with HNSCC (>20% combined positive score) and NSCLC (>20% PD-L1 expression)\n5. Measurable disease according to iRECIST\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Progressive disease, as considered by the treating physician, on therapy with PD1/PD-L1 blockers and/or CTLA4-blockers and/or LAG-3 blockers, or combinations regimes comprising any of these agents. Further treatment with ICI is considered to be within standard practice.\n8. Patients without any response to ICI at any time point during their disease history are eligible, without a need for re-introduction of ICI before enrollment, even if subsequent lines of anti-cancer therapy have been given. For patients with prior response to ICI, the criteria depend on the cancer form:\n\n   1. Malignant melanoma, NSCLC and MSI-H/dMMR solid cancers: Prior response to ICI is allowed only if PD under ICI has been documented <9 months before enrolment and without subsequent lines of anti-cancer therapy. For patients with prior response to ICI followed by subsequent lines of anti-cancer therapy, and patients that have not received ICI the last 9 months, ICI has to be re-introduced, and these patients have to again show progressive disease while on ICI therapy.\n   2. CSCC, HNSCC and renal clear cell carcinoma: Prior response to ICI is allowed, without a need for re-introduction, even if subsequent lines of anti-cancer therapy have been given, provided that disease progression has been documented under ICI therapy the last 12 months.\n9. Mandatory pre-FMT biopsy and lesion accessible for further biopsies\n10. Life expectancy >3 months\n11. Adequate organ function as defined below:\n\n    1. Hemoglobin > 9 g/dL\n    2. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L\n    3. Platelet count ≥80 x 109/L\n    4. INR≤1.2\n    5. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).\n    6. AST and ALT ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN\n    7. Albumin >25 g/L\n    8. Serum creatinine ≤1.5 X ULN OR measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n12. Capable of giving signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Other cancer within 3 years prior to study entry, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)\n2. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to first FMT\n3. Uncontrolled pleural effusion, pericardial effusion, or ascites. Patients with indwelling catheters are allowed\n4. Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrolment. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrolment.\n5. Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to study entry, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction (LVEF) < 40% will be excluded. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate\n6. Undergone allogeneic stem cell or solid organ transplantation\n7. A positive test for HIV\n8. Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HbsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n9. Active tuberculosis\n10. Ongoing immune-related adverse effects from immunotherapy treatments that are of Grade ≥2, excluding endocrine adverse effects. An ongoing grade 2 cutaneous reaction is allowed.\n11. Severe infection within 14 days prior to first FMT, requiring hospitalization.\n12. Any condition that significantly increases the risk of perforation during endoscopy for FMT.\n13. A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n14. Known psychiatric or substance abuse disorders that would interfere with cooperation and the requirements of the trial\n15. A requirement of systemic antibiotics at the time of study entry.\n16. Received oral or IV antibiotics within 5 days prior to first FMT.\n17. Currently receiving other study therapy that may interfere with the interpretation of data in this study.\n18. Received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 10 days prior to first FMT, or anticipated requirement for systemic immunosuppressive medications during the trial. A daily dose equivalent to ≤10mg prednisolone is allowed.\n\n    1. Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study.\n    2. Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using MRI.\n    3. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.\n19. Pregnant or breastfeeding\n20. Any reason why, in the opinion of the investigator, the patient should not participate",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Participant must be 18 years of age, at the time of signing the informed consent",
            "criterions": [
                {
                    "exact_snippets": "Participant must be 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically confirmed malignant melanoma, NSCLC, CSCC, HNSCC, renal clear cell carcinoma or MSI+ solid cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed malignant melanoma",
                    "criterion": "malignant melanoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... CSCC",
                    "criterion": "CSCC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... HNSCC",
                    "criterion": "HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... renal clear cell carcinoma",
                    "criterion": "renal clear cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... MSI+ solid cancer",
                    "criterion": "MSI+ solid cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Metastatic disease or local recurrence not curable by standard therapy",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "curability by standard therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "local recurrence not curable by standard therapy",
                    "criterion": "local recurrence",
                    "requirements": [
                        {
                            "requirement_type": "curability by standard therapy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. PD-L1 positivity is required for subjects with HNSCC (>20% combined positive score) and NSCLC (>20% PD-L1 expression)",
            "criterions": [
                {
                    "exact_snippets": "PD-L1 positivity is required for subjects with HNSCC (>20% combined positive score)",
                    "criterion": "PD-L1 positivity in HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "combined positive score",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PD-L1 positivity is required for subjects with ... NSCLC (>20% PD-L1 expression)",
                    "criterion": "PD-L1 positivity in NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "PD-L1 expression",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Measurable disease according to iRECIST",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease according to iRECIST",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "according to iRECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Progressive disease, as considered by the treating physician, on therapy with PD1/PD-L1 blockers and/or CTLA4-blockers and/or LAG-3 blockers, or combinations regimes comprising any of these agents. Further treatment with ICI is considered to be within standard practice.",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease, as considered by the treating physician, on therapy with PD1/PD-L1 blockers",
                    "criterion": "progressive disease on PD1/PD-L1 blockers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive disease, as considered by the treating physician, on therapy with ... CTLA4-blockers",
                    "criterion": "progressive disease on CTLA4-blockers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive disease, as considered by the treating physician, on therapy with ... LAG-3 blockers",
                    "criterion": "progressive disease on LAG-3 blockers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients without any response to ICI at any time point during their disease history are eligible, without a need for re-introduction of ICI before enrollment, even if subsequent lines of anti-cancer therapy have been given. For patients with prior response to ICI, the criteria depend on the cancer form:",
            "criterions": [
                {
                    "exact_snippets": "Patients without any response to ICI at any time point during their disease history",
                    "criterion": "response to ICI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without a need for re-introduction of ICI before enrollment",
                    "criterion": "re-introduction of ICI",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "even if subsequent lines of anti-cancer therapy have been given",
                    "criterion": "subsequent lines of anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Malignant melanoma, NSCLC and MSI-H/dMMR solid cancers: Prior response to ICI is allowed only if PD under ICI has been documented <9 months before enrolment and without subsequent lines of anti-cancer therapy. For patients with prior response to ICI followed by subsequent lines of anti-cancer therapy, and patients that have not received ICI the last 9 months, ICI has to be re-introduced, and these patients have to again show progressive disease while on ICI therapy.",
            "criterions": [
                {
                    "exact_snippets": "Malignant melanoma, NSCLC and MSI-H/dMMR solid cancers",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "Malignant melanoma",
                                "NSCLC",
                                "MSI-H/dMMR solid cancers"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior response to ICI is allowed only if PD under ICI has been documented <9 months before enrolment",
                    "criterion": "prior response to ICI",
                    "requirements": [
                        {
                            "requirement_type": "documentation of PD under ICI",
                            "expected_value": {
                                "operator": "<",
                                "value": 9,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without subsequent lines of anti-cancer therapy",
                    "criterion": "subsequent lines of anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with prior response to ICI followed by subsequent lines of anti-cancer therapy",
                    "criterion": "prior response to ICI with subsequent lines of anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients that have not received ICI the last 9 months",
                    "criterion": "ICI therapy in the last 9 months",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ICI has to be re-introduced",
                    "criterion": "ICI re-introduction",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "these patients have to again show progressive disease while on ICI therapy",
                    "criterion": "progressive disease on ICI therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. CSCC, HNSCC and renal clear cell carcinoma: Prior response to ICI is allowed, without a need for re-introduction, even if subsequent lines of anti-cancer therapy have been given, provided that disease progression has been documented under ICI therapy the last 12 months.",
            "criterions": [
                {
                    "exact_snippets": "CSCC, HNSCC and renal clear cell carcinoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "CSCC",
                                "HNSCC",
                                "renal clear cell carcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior response to ICI is allowed",
                    "criterion": "prior response to ICI",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "allowed"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression has been documented under ICI therapy the last 12 months",
                    "criterion": "disease progression under ICI therapy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Mandatory pre-FMT biopsy and lesion accessible for further biopsies",
            "criterions": [
                {
                    "exact_snippets": "Mandatory pre-FMT biopsy",
                    "criterion": "pre-FMT biopsy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion accessible for further biopsies",
                    "criterion": "lesion accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Life expectancy >3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Adequate organ function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Hemoglobin > 9 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.0 x 109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Platelet count ≥80 x 109/L",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥80 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. INR≤1.2",
            "criterions": [
                {
                    "exact_snippets": "INR≤1.2",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).",
            "criterions": [
                {
                    "exact_snippets": "Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. AST and ALT ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN",
            "criterions": [
                {
                    "exact_snippets": "AST and ALT ≤2.5 x ULN",
                    "criterion": "AST and ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless liver metastases are present, in which case it must be ≤5x ULN",
                    "criterion": "AST and ALT levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Albumin >25 g/L",
            "criterions": [
                {
                    "exact_snippets": "Albumin >25 g/L",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Serum creatinine ≤1.5 X ULN OR measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤1.5 X ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured creatinine clearance (CL) >40 mL/min",
                    "criterion": "measured creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula",
                    "criterion": "calculated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24-hour urine collection for determination of creatinine clearance",
                    "criterion": "creatinine clearance by 24-hour urine collection",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "24-hour urine collection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Capable of giving signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Capable of giving signed informed consent",
                    "criterion": "capability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Other cancer within 3 years prior to study entry, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)",
            "criterions": [
                {
                    "exact_snippets": "Other cancer within 3 years prior to study entry",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of those with a negligible risk of metastasis or death",
                    "criterion": "negligible risk of metastasis or death",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "negligible"
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with expected curative outcome",
                    "criterion": "treatment outcome",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to first FMT",
            "criterions": [
                {
                    "exact_snippets": "Spinal cord compression not definitively treated with surgery and/or radiation",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "not definitively treated with surgery and/or radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to first FMT",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "previously diagnosed and treated"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Uncontrolled pleural effusion, pericardial effusion, or ascites. Patients with indwelling catheters are allowed",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrolment. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrolment.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled tumor-related pain",
                    "criterion": "tumor-related pain",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients requiring narcotic pain medication must be on a stable regimen at study entry",
                    "criterion": "narcotic pain medication regimen",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic lesions ... should be treated prior to enrolment",
                    "criterion": "symptomatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "prior to enrolment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain ... should be considered for loco-regional therapy if appropriate prior to enrolment",
                    "criterion": "asymptomatic metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "consideration for loco-regional therapy",
                            "expected_value": "prior to enrolment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to study entry, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction (LVEF) < 40% will be excluded. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate",
            "criterions": [
                {
                    "exact_snippets": "Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater)",
                    "criterion": "NYHA cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 3 months prior to study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a known left ventricular ejection fraction (LVEF) < 40% will be excluded",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "medical regimen",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "medical regimen",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "medical regimen",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Undergone allogeneic stem cell or solid organ transplantation",
            "criterions": [
                {
                    "exact_snippets": "Undergone allogeneic stem cell or solid organ transplantation",
                    "criterion": "allogeneic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Undergone allogeneic stem cell or solid organ transplantation",
                    "criterion": "solid organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. A positive test for HIV",
            "criterions": [
                {
                    "exact_snippets": "A positive test for HIV",
                    "criterion": "HIV test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HbsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening)",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HbsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible.",
                    "criterion": "past or resolved hepatitis B virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.",
                    "criterion": "hepatitis C virus (HCV) antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HCV RNA",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Active tuberculosis",
            "criterions": [
                {
                    "exact_snippets": "Active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Ongoing immune-related adverse effects from immunotherapy treatments that are of Grade ≥2, excluding endocrine adverse effects. An ongoing grade 2 cutaneous reaction is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing immune-related adverse effects from immunotherapy treatments",
                    "criterion": "immune-related adverse effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that are of Grade ≥2",
                    "criterion": "adverse effect grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding endocrine adverse effects",
                    "criterion": "endocrine adverse effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "An ongoing grade 2 cutaneous reaction is allowed",
                    "criterion": "cutaneous reaction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Severe infection within 14 days prior to first FMT, requiring hospitalization.",
            "criterions": [
                {
                    "exact_snippets": "Severe infection within 14 days prior to first FMT",
                    "criterion": "severe infection",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days prior to first FMT"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring hospitalization",
                    "criterion": "hospitalization",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Any condition that significantly increases the risk of perforation during endoscopy for FMT.",
            "criterions": [
                {
                    "exact_snippets": "condition that significantly increases the risk of perforation during endoscopy",
                    "criterion": "condition increasing risk of perforation during endoscopy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.",
            "criterions": [
                {
                    "exact_snippets": "A history or current evidence of any condition",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history or current evidence of any ... therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history or current evidence of any ... laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Known psychiatric or substance abuse disorders that would interfere with cooperation and the requirements of the trial",
            "criterions": [
                {
                    "exact_snippets": "Known psychiatric or substance abuse disorders",
                    "criterion": "psychiatric or substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. A requirement of systemic antibiotics at the time of study entry.",
            "criterions": [
                {
                    "exact_snippets": "requirement of systemic antibiotics",
                    "criterion": "systemic antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Received oral or IV antibiotics within 5 days prior to first FMT.",
            "criterions": [
                {
                    "exact_snippets": "Received oral or IV antibiotics within 5 days prior to first FMT.",
                    "criterion": "antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "route of administration",
                            "expected_value": [
                                "oral",
                                "IV"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Currently receiving other study therapy that may interfere with the interpretation of data in this study.",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving other study therapy",
                    "criterion": "other study therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "may interfere with the interpretation of data in this study",
                    "criterion": "interference with data interpretation",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 10 days prior to first FMT, or anticipated requirement for systemic immunosuppressive medications during the trial. A daily dose equivalent to ≤10mg prednisolone is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 10 days prior to first FMT",
                    "criterion": "treatment with systemic corticosteroids or other systemic immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 10 days prior to first FMT"
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipated requirement for systemic immunosuppressive medications during the trial",
                    "criterion": "requirement for systemic immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "anticipated",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A daily dose equivalent to ≤10mg prednisolone is allowed",
                    "criterion": "daily dose of prednisolone",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea)",
                    "criterion": "acute, low-dose, systemic immunosuppressant medications",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using MRI.",
            "criterions": [
                {
                    "exact_snippets": "history of allergic reaction to IV contrast",
                    "criterion": "allergic reaction to IV contrast",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring steroid pre-treatment",
                    "criterion": "steroid pre-treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.",
            "criterions": [
                {
                    "exact_snippets": "The use of inhaled corticosteroids for chronic obstructive pulmonary disease ... are allowed.",
                    "criterion": "inhaled corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "chronic obstructive pulmonary disease"
                        },
                        {
                            "requirement_type": "usage",
                            "expected_value": "allowed"
                        }
                    ]
                },
                {
                    "exact_snippets": "The use of ... mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension ... are allowed.",
                    "criterion": "mineralocorticoids",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "orthostatic hypotension"
                        },
                        {
                            "requirement_type": "usage",
                            "expected_value": "allowed"
                        }
                    ]
                },
                {
                    "exact_snippets": "The use of ... low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.",
                    "criterion": "low-dose supplemental corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "adrenocortical insufficiency"
                        },
                        {
                            "requirement_type": "usage",
                            "expected_value": "allowed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Any reason why, in the opinion of the investigator, the patient should not participate",
            "criterions": [
                {
                    "exact_snippets": "Any reason why, in the opinion of the investigator, the patient should not participate",
                    "criterion": "investigator's opinion on participation",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "no reason to exclude"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}