{
    "info": {
        "nct_id": "NCT05039060",
        "official_title": "A Modified Microbiota-Accessible Carbohydrates (MAC) Diet and Change of Gut Microbiota in Patients With Colorectal Cancer After Surgery: A Prospective, Open-label, Cross-over, Single Center Study",
        "inclusion_criteria": "1. Histologically or cytologically confirmed colorectal adenocarcinoma patients after curative surgery without post-operative chemotherapy (stage I and low-risk stage II)\n2. Male of female participants over the age of 19\n3. Eastern Cooperative Oncology Group (ECOG) performance score 0-2\n4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol\n5. Adequate hematologic and end-organ function\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
        "exclusion_criteria": "1. Patients with temporary/permanent stoma after surgery\n2. Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer which require postoperative chemotherapy after surgery\n3. Diagnosed with metastatic stage IV colorectal cancer after surgery\n4. Uncontrolled diabetes (glycated hemoglobin A1c (HbA1c) > 8.0 g/dl)\n5. Active infection requiring antibiotics, antifungal or antiviral agents or received a course of antibiotics within 4 weeks prior to study treatments\n6. Known history of food allergy\n7. Known history of uncontrolled intercurrent illness including but not limited to: Infection/inflammation; severe liver dysfunction; bilateral interstitial lung disease; uncontrolled kidney disease; clinically significant (active) cardiovascular and pulmonary disease; hemorrhagic disease; inflammatory bowel disease, intestinal obstruction; Inability to swallow food; social and psychological problems etc.)\n8. Other medical and psychiatric conditions that would prohibit the understanding or rendering of informed consent which affect study compliance",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically or cytologically confirmed colorectal adenocarcinoma patients after curative surgery without post-operative chemotherapy (stage I and low-risk stage II)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed colorectal adenocarcinoma",
                    "criterion": "colorectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients after curative surgery",
                    "criterion": "curative surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without post-operative chemotherapy",
                    "criterion": "post-operative chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I and low-risk stage II",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "stage I",
                                "low-risk stage II"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eastern Cooperative Oncology Group (ECOG) performance score 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance score 0-2",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol",
            "criterions": [
                {
                    "exact_snippets": "Capable of giving signed informed consent",
                    "criterion": "signed informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "compliance with the requirements and restrictions listed in the informed consent form and in this protocol",
                    "criterion": "compliance with informed consent requirements",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate hematologic and end-organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... end-organ function",
                    "criterion": "end-organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with temporary/permanent stoma after surgery",
            "criterions": [
                {
                    "exact_snippets": "temporary/permanent stoma after surgery",
                    "criterion": "stoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "temporary",
                                "permanent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer which require postoperative chemotherapy after surgery",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer",
                    "criterion": "colorectal cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "locally advanced stage (more than high-risk stage II)"
                        }
                    ]
                },
                {
                    "exact_snippets": "require postoperative chemotherapy after surgery",
                    "criterion": "postoperative chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Diagnosed with metastatic stage IV colorectal cancer after surgery",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with metastatic stage IV colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic stage IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "after surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Uncontrolled diabetes (glycated hemoglobin A1c (HbA1c) > 8.0 g/dl)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "glycated hemoglobin A1c (HbA1c) > 8.0 g/dl",
                    "criterion": "glycated hemoglobin A1c (HbA1c)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Active infection requiring antibiotics, antifungal or antiviral agents or received a course of antibiotics within 4 weeks prior to study treatments",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring antibiotics, antifungal or antiviral agents",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "antibiotics",
                                "antifungal agents",
                                "antiviral agents"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "received a course of antibiotics within 4 weeks prior to study treatments",
                    "criterion": "antibiotic treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last course",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Known history of food allergy",
            "criterions": [
                {
                    "exact_snippets": "Known history of food allergy",
                    "criterion": "food allergy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Known history of uncontrolled intercurrent illness including but not limited to: Infection/inflammation; severe liver dysfunction; bilateral interstitial lung disease; uncontrolled kidney disease; clinically significant (active) cardiovascular and pulmonary disease; hemorrhagic disease; inflammatory bowel disease, intestinal obstruction; Inability to swallow food; social and psychological problems etc.)",
            "criterions": [
                {
                    "exact_snippets": "Known history of uncontrolled intercurrent illness including but not limited to: Infection/inflammation",
                    "criterion": "uncontrolled intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe liver dysfunction",
                    "criterion": "severe liver dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral interstitial lung disease",
                    "criterion": "bilateral interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled kidney disease",
                    "criterion": "uncontrolled kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant (active) cardiovascular and pulmonary disease",
                    "criterion": "clinically significant cardiovascular and pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemorrhagic disease",
                    "criterion": "hemorrhagic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to swallow food",
                    "criterion": "inability to swallow food",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "social and psychological problems",
                    "criterion": "social and psychological problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Other medical and psychiatric conditions that would prohibit the understanding or rendering of informed consent which affect study compliance",
            "criterions": [
                {
                    "exact_snippets": "Other medical and psychiatric conditions that would prohibit the understanding or rendering of informed consent",
                    "criterion": "medical and psychiatric conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on informed consent",
                            "expected_value": "prohibit understanding or rendering"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other medical and psychiatric conditions ... which affect study compliance",
                    "criterion": "medical and psychiatric conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study compliance",
                            "expected_value": "affect"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "2. Male of female participants over the age of 19",
            "criterions": [
                {
                    "exact_snippets": "Male or female participants",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "over the age of 19",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 19,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}