{
    "info": {
        "nct_id": "NCT06738173",
        "official_title": "A Gut Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer",
        "inclusion_criteria": "* Patients participating in the national CRC screening program (50-69 yearold)\n* Positivity to the FIT;\n* Ability to provide written informed consent and to be compliant with the study procedures.\nHealthy volunteers allowed\nMust have minimum age of 50 Years\nMust have maximum age of 69 Years",
        "exclusion_criteria": "* Patients unfit for colonoscopy;\n* Other oncological conditions;\n* Concomitant severe comorbidities or gastrointestinal (GI) organic diseases (e.g. diverticular disease, inflammatory bowel disease);\n* Antibiotics or probiotics within 4 weeks prior to enrollment;\n* Chronic therapy (>12 weeks) with proton pump inhibitors.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients participating in the national CRC screening program (50-69 yearold)",
            "criterions": [
                {
                    "exact_snippets": "Patients participating in the national CRC screening program",
                    "criterion": "participation in national CRC screening program",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "50-69 yearold",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 69,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positivity to the FIT;",
            "criterions": [
                {
                    "exact_snippets": "Positivity to the FIT",
                    "criterion": "FIT (Fecal Immunochemical Test)",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to provide written informed consent and to be compliant with the study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to be compliant with the study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 69 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 69 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 69,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients unfit for colonoscopy;",
            "criterions": [
                {
                    "exact_snippets": "Patients unfit for colonoscopy",
                    "criterion": "fitness for colonoscopy",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other oncological conditions;",
            "criterions": [
                {
                    "exact_snippets": "Other oncological conditions",
                    "criterion": "oncological conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant severe comorbidities or gastrointestinal (GI) organic diseases (e.g. diverticular disease, inflammatory bowel disease);",
            "criterions": [
                {
                    "exact_snippets": "Concomitant severe comorbidities",
                    "criterion": "severe comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal (GI) organic diseases",
                    "criterion": "gastrointestinal organic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "diverticular disease",
                    "criterion": "diverticular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antibiotics or probiotics within 4 weeks prior to enrollment;",
            "criterions": [
                {
                    "exact_snippets": "Antibiotics ... within 4 weeks prior to enrollment",
                    "criterion": "antibiotics usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "probiotics within 4 weeks prior to enrollment",
                    "criterion": "probiotics usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Chronic therapy (&amp;gt;12 weeks) with proton pump inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "Chronic therapy (>12 weeks) with proton pump inhibitors.",
                    "criterion": "proton pump inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}