{
"info": {
"nct_id": "NCT04211766",
"official_title": "Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans",
"inclusion_criteria": "* Healthy\n* Normal-overweight (body mass index [BMI] of 18-30 kg/m^2)\n* Women will be postmenopausal, with no menstrual period in 12 months\n* Non-smoking\n* Consume fiber intakes of less than < 20 g/d\n* White blood cell count 3,000-11,000/mm^3\n* Platelet count 100,000-400,000 mm^3\n* Hematocrit 33-50% (women); 36-50% (men)\n* Bilirubin 0.2-1.3 mg/dL\n* Aspartate aminotransferase (AST) 0-35 U/L\n* Alanine aminotransferase (ALT) 0-40 U/L\n* Alkaline phosphatase 20-125 U/L\n* Creatinine =< 1.2 mg/dL\n* Potassium 3.5-5.0 mmol/L\nHealthy volunteers allowed\nMust have minimum age of 50 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer [HNPCC], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer)\n* Weight change greater than 4.5 kg within past year\n* Oral or intravenous (IV) antibiotic use within the past 3 months\n* Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Smoking or use of cannabis products\n* Known allergy to fish\n* Intention to relocate out of study area within next 4 months",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Healthy",
"criterions": [
{
"exact_snippets": "Healthy",
"criterion": "health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy",
"criterion": "health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "* Normal-overweight (body mass index [BMI] of 18-30 kg/m^2)",
"criterions": [
{
"exact_snippets": "body mass index [BMI] of 18-30 kg/m^2",
"criterion": "body mass index (BMI)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "kg/m^2"
},
{
"operator": "<=",
"value": 30,
"unit": "kg/m^2"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "body mass index [BMI] of 18-30 kg/m^2",
"criterion": "body mass index (BMI)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "kg/m^2"
},
{
"operator": "<=",
"value": 30,
"unit": "kg/m^2"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Women will be postmenopausal, with no menstrual period in 12 months",
"criterions": [
{
"exact_snippets": "Women will be postmenopausal",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
},
{
"exact_snippets": "no menstrual period in 12 months",
"criterion": "menstrual period",
"requirement": {
"requirement_type": "absence duration",
"expected_value": {
"operator": "=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women will be postmenopausal",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
},
{
"exact_snippets": "no menstrual period in 12 months",
"criterion": "menstrual period",
"requirement": {
"requirement_type": "absence duration",
"expected_value": {
"operator": "=",
"value": 12,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Non-smoking",
"criterions": [
{
"exact_snippets": "Non-smoking",
"criterion": "smoking status",
"requirement": {
"requirement_type": "status",
"expected_value": "non-smoker"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Non-smoking",
"criterion": "smoking status",
"requirement": {
"requirement_type": "status",
"expected_value": "non-smoker"
}
}
]
}
},
{
"identified_line": {
"line": "* Consume fiber intakes of less than < 20 g/d",
"criterions": [
{
"exact_snippets": "Consume fiber intakes of less than < 20 g/d",
"criterion": "fiber intake",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 20,
"unit": "g/d"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Consume fiber intakes of less than < 20 g/d",
"criterion": "fiber intake",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 20,
"unit": "g/d"
}
}
}
]
}
},
{
"identified_line": {
"line": "* White blood cell count 3,000-11,000/mm^3",
"criterions": [
{
"exact_snippets": "White blood cell count 3,000-11,000/mm^3",
"criterion": "white blood cell count",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3000,
"unit": "mm^3"
},
{
"operator": "<=",
"value": 11000,
"unit": "mm^3"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "White blood cell count 3,000-11,000/mm^3",
"criterion": "white blood cell count",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3000,
"unit": "mm^3"
},
{
"operator": "<=",
"value": 11000,
"unit": "mm^3"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count 100,000-400,000 mm^3",
"criterions": [
{
"exact_snippets": "Platelet count 100,000-400,000 mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 100000,
"unit": "mm^3"
},
{
"operator": "<=",
"value": 400000,
"unit": "mm^3"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelet count 100,000-400,000 mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 100000,
"unit": "mm^3"
},
{
"operator": "<=",
"value": 400000,
"unit": "mm^3"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hematocrit 33-50% (women); 36-50% (men)",
"criterions": [
{
"exact_snippets": "Hematocrit 33-50% (women)",
"criterion": "hematocrit",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 33,
"unit": "%"
},
{
"operator": "<=",
"value": 50,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "Hematocrit ... 36-50% (men)",
"criterion": "hematocrit",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 36,
"unit": "%"
},
{
"operator": "<=",
"value": 50,
"unit": "%"
}
]
}
}
}
]
},
"logical_structure": {
"xor_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Hematocrit 33-50% (women)",
"criterion": "hematocrit",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 33,
"unit": "%"
},
{
"operator": "<=",
"value": 50,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "Hematocrit ... 36-50% (men)",
"criterion": "gender",
"requirement": {
"requirement_type": "equality",
"expected_value": "female"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Hematocrit ... 36-50% (men)",
"criterion": "hematocrit",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 36,
"unit": "%"
},
{
"operator": "<=",
"value": 50,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "Hematocrit ... 36-50% (men)",
"criterion": "gender",
"requirement": {
"requirement_type": "equality",
"expected_value": "male"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin 0.2-1.3 mg/dL",
"criterions": [
{
"exact_snippets": "Bilirubin 0.2-1.3 mg/dL",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0.2,
"unit": "mg/dL"
},
{
"operator": "<=",
"value": 1.3,
"unit": "mg/dL"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Bilirubin 0.2-1.3 mg/dL",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0.2,
"unit": "mg/dL"
},
{
"operator": "<=",
"value": 1.3,
"unit": "mg/dL"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Aspartate aminotransferase (AST) 0-35 U/L",
"criterions": [
{
"exact_snippets": "Aspartate aminotransferase (AST) 0-35 U/L",
"criterion": "Aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "U/L"
},
{
"operator": "<=",
"value": 35,
"unit": "U/L"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Aspartate aminotransferase (AST) 0-35 U/L",
"criterion": "Aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "U/L"
},
{
"operator": "<=",
"value": 35,
"unit": "U/L"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Alanine aminotransferase (ALT) 0-40 U/L",
"criterions": [
{
"exact_snippets": "Alanine aminotransferase (ALT) 0-40 U/L",
"criterion": "Alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "U/L"
},
{
"operator": "<=",
"value": 40,
"unit": "U/L"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Alanine aminotransferase (ALT) 0-40 U/L",
"criterion": "Alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "U/L"
},
{
"operator": "<=",
"value": 40,
"unit": "U/L"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Alkaline phosphatase 20-125 U/L",
"criterions": [
{
"exact_snippets": "Alkaline phosphatase 20-125 U/L",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20,
"unit": "U/L"
},
{
"operator": "<=",
"value": 125,
"unit": "U/L"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Alkaline phosphatase 20-125 U/L",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20,
"unit": "U/L"
},
{
"operator": "<=",
"value": 125,
"unit": "U/L"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine =< 1.2 mg/dL",
"criterions": [
{
"exact_snippets": "Creatinine =< 1.2 mg/dL",
"criterion": "creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.2,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Creatinine =< 1.2 mg/dL",
"criterion": "creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.2,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Potassium 3.5-5.0 mmol/L",
"criterions": [
{
"exact_snippets": "Potassium 3.5-5.0 mmol/L",
"criterion": "potassium level",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3.5,
"unit": "mmol/L"
},
{
"operator": "<=",
"value": 5.0,
"unit": "mmol/L"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Potassium 3.5-5.0 mmol/L",
"criterion": "potassium level",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3.5,
"unit": "mmol/L"
},
{
"operator": "<=",
"value": 5.0,
"unit": "mmol/L"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Weight change greater than 4.5 kg within past year",
"criterions": [
{
"exact_snippets": "Weight change greater than 4.5 kg within past year",
"criterion": "weight change",
"requirement": {
"requirement_type": "amount",
"expected_value": {
"operator": ">",
"value": 4.5,
"unit": "kg"
}
}
},
{
"exact_snippets": "Weight change greater than 4.5 kg within past year",
"criterion": "weight change",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within past year"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Weight change greater than 4.5 kg within past year",
"criterion": "weight change",
"requirement": {
"requirement_type": "amount",
"expected_value": {
"operator": ">",
"value": 4.5,
"unit": "kg"
}
}
},
{
"exact_snippets": "Weight change greater than 4.5 kg within past year",
"criterion": "weight change",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within past year"
}
}
]
}
},
{
"identified_line": {
"line": "* Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)",
"criterions": [
{
"exact_snippets": "Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)",
"criterion": "use of aspirin or NSAIDs",
"requirement": {
"requirement_type": "regularity",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)",
"criterion": "use of aspirin or NSAIDs",
"requirement": {
"requirement_type": "regularity",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Smoking or use of cannabis products",
"criterions": [
{
"exact_snippets": "Smoking",
"criterion": "smoking",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "use of cannabis products",
"criterion": "cannabis use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Smoking",
"criterion": "smoking",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "use of cannabis products",
"criterion": "cannabis use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Known allergy to fish",
"criterions": [
{
"exact_snippets": "Known allergy to fish",
"criterion": "allergy to fish",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Known allergy to fish",
"criterion": "allergy to fish",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Intention to relocate out of study area within next 4 months",
"criterions": [
{
"exact_snippets": "Intention to relocate out of study area",
"criterion": "intention to relocate",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within next 4 months"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Intention to relocate out of study area",
"criterion": "intention to relocate",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within next 4 months"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer [HNPCC], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer)",
"criterions": [
{
"exact_snippets": "Chronic medical illness",
"criterion": "chronic medical illness",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of gastrointestinal disorders",
"criterion": "gastrointestinal disorders",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "ulcerative colitis",
"criterion": "ulcerative colitis",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "Crohn disease",
"criterion": "Crohn disease",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "celiac sprue",
"criterion": "celiac sprue",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "hereditary nonpolyposis colorectal cancer [HNPCC]",
"criterion": "hereditary nonpolyposis colorectal cancer",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "familial adenomatous polyposis",
"criterion": "familial adenomatous polyposis",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "pancreatic disease",
"criterion": "pancreatic disease",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "previous gastrointestinal resection",
"criterion": "previous gastrointestinal resection",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "radiation or chemotherapy",
"criterion": "radiation or chemotherapy",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "cancer (other than non-melanoma skin cancer)",
"criterion": "cancer",
"requirement": {
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}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
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}
}
},
{
"identified_line": {
"line": "* Oral or intravenous (IV) antibiotic use within the past 3 months",
"criterions": [
{
"exact_snippets": "Oral or intravenous (IV) antibiotic use within the past 3 months",
"criterion": "antibiotic use",
"requirement": {
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"intravenous"
]
}
},
{
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"criterion": "antibiotic use",
"requirement": {
"requirement_type": "time frame",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Oral or intravenous (IV) antibiotic use within the past 3 months",
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}
},
{
"exact_snippets": "Oral or intravenous (IV) antibiotic use within the past 3 months",
"criterion": "antibiotic use",
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}
}
]
},
{
"exact_snippets": "Oral or intravenous (IV) antibiotic use within the past 3 months",
"criterion": "antibiotic use",
"requirement": {
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"expected_value": "within the past 3 months"
}
}
]
}
}
],
"failed_miscellaneous": []
}