Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 9:46 AM
Study NCT ID:
NCT03983434
Status:
TERMINATED
Last Update Posted:
2025-04-30
First Post:
2019-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007444', 'term': 'Inulin'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005630', 'term': 'Fructans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'huipxu@iu.edu', 'phone': '317-278-6735', 'title': 'Dr. Huiping Xu', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.", 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.", 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.", 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Fecal Bile Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '471.5', 'groupId': 'OG000', 'lowerLimit': '331.5', 'upperLimit': '612.5'}, {'value': '347', 'groupId': 'OG001', 'lowerLimit': '159', 'upperLimit': '535'}, {'value': '329.5', 'groupId': 'OG002', 'lowerLimit': '145', 'upperLimit': '515'}]}]}], 'analyses': [{'pValue': '.62', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectometry', 'unitOfMeasure': 'mcmol/48 hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Fecal Short Chain Fatty Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '359.8', 'groupId': 'OG000', 'lowerLimit': '233.1', 'upperLimit': '473.2'}, {'value': '157.1', 'groupId': 'OG001', 'lowerLimit': '157.1', 'upperLimit': '157.1'}, {'value': '276.9', 'groupId': 'OG002', 'lowerLimit': '168.6', 'upperLimit': '408.1'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry', 'unitOfMeasure': 'mmol/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing data in short chain fatty acids.'}, {'type': 'PRIMARY', 'title': 'Individual Fecal Short Chain Fatty Acids - Acetate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '255.7', 'groupId': 'OG000', 'lowerLimit': '147.5', 'upperLimit': '300.1'}, {'value': '113.9', 'groupId': 'OG001', 'lowerLimit': '113.9', 'upperLimit': '113.9'}, {'value': '202.5', 'groupId': 'OG002', 'lowerLimit': '121.7', 'upperLimit': '266'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry', 'unitOfMeasure': 'mmol/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing data in short chain fatty acids'}, {'type': 'PRIMARY', 'title': 'Individual Fecal Short Chain Fatty Acids - Propionate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '86'}, {'value': '22.8', 'groupId': 'OG001', 'lowerLimit': '22.8', 'upperLimit': '22.8'}, {'value': '39.1', 'groupId': 'OG002', 'lowerLimit': '25.3', 'upperLimit': '51.1'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry', 'unitOfMeasure': 'mmol/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing short chain fatty acids'}, {'type': 'PRIMARY', 'title': 'Individual Fecal Short Chain Fatty Acids - Butyrate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '70.2'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '20.5'}, {'value': '37.6', 'groupId': 'OG002', 'lowerLimit': '16.9', 'upperLimit': '91'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry', 'unitOfMeasure': 'mmol/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fecal Microbial Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '3.5'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiome sequencing was completed on all collected specimens.'}, {'type': 'PRIMARY', 'title': 'Fecal Inulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '5.4'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography', 'unitOfMeasure': '% of fructose from inulin/total fructose', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Measures of inulin evolved over time and many subjects did not have inulin measured as a fraction.'}, {'type': 'SECONDARY', 'title': 'Percent Primary Fecal Bile Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '26.8'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '10.3'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectrometry. Percent primary bile acids is then calculated as primary bile acids divided by total bile acids multiplied by 100.', 'unitOfMeasure': '% of primary/total fecal bile acids', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Characteristics - Stool Frequency in 4 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5.5'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '4 days', 'description': 'Stool characteristics will be measured using a 4 day bowel diary. Stool frequency is the total number of bowel movements in 4 days summarized on the subject level.', 'unitOfMeasure': 'Number of bowel movements in 4 days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Characteristics - Stool Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'units': 'Bowel movements', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '4 days', 'description': 'Stool characteristics will be measured using a 4 day bowel diary. Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage,3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy,7=watery, summarized on the level of bowel movements.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bowel movements', 'denomUnitsSelected': 'Bowel movements'}, {'type': 'SECONDARY', 'title': 'Stool Characteristics - Ease of Passage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'units': 'Bowel movements', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '4 days', 'description': 'Stool characteristics will be measured using a 4 day bowel diary. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bowel movements', 'denomUnitsSelected': 'Bowel movements'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'OG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'classes': [{'categories': [{'measurements': [{'value': '1887.6', 'groupId': 'OG000', 'lowerLimit': '1563.9', 'upperLimit': '2507.5'}, {'value': '2083.8', 'groupId': 'OG001', 'lowerLimit': '1801.3', 'upperLimit': '2366.4'}, {'value': '2246.4', 'groupId': 'OG002', 'lowerLimit': '1540.1', 'upperLimit': '2509.8'}]}]}], 'analyses': [{'pValue': '0.98', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the skewness of the data, outcome measures were summarized using median and interquartile range.'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Optional 24-hour dietary intake will be submitted using web-based Automated Self-Administered Dietary Assessment Tool developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24/). Dietary intake within a 24-hour period in 30-90 days after study enrollment were collected.', 'unitOfMeasure': 'kcal', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'FG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'FG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Volunteers', 'description': "Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'BG001', 'title': 'Irritable Bowel Syndrome Patients With Constipation', 'description': "Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'BG002', 'title': 'Irritable Bowel Syndrome Patients With Diarrhea', 'description': "Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS\n\nInulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '6', 'groupId': 'BG001'}, {'value': '36.1', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '35.2', 'spread': '12.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-04', 'size': 461301, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-18T17:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Study physician left the university', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2019-06-06', 'resultsFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-11', 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Energy', 'timeFrame': '24 hours', 'description': 'Optional 24-hour dietary intake will be submitted using web-based Automated Self-Administered Dietary Assessment Tool developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24/). Dietary intake within a 24-hour period in 30-90 days after study enrollment were collected.'}], 'primaryOutcomes': [{'measure': 'Total Fecal Bile Acids', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectometry'}, {'measure': 'Total Fecal Short Chain Fatty Acids', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry'}, {'measure': 'Individual Fecal Short Chain Fatty Acids - Acetate', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry'}, {'measure': 'Individual Fecal Short Chain Fatty Acids - Propionate', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry'}, {'measure': 'Individual Fecal Short Chain Fatty Acids - Butyrate', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry'}, {'measure': 'Fecal Microbial Population', 'timeFrame': '48 hours', 'description': 'Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is.'}, {'measure': 'Fecal Inulin', 'timeFrame': '48 hours', 'description': 'Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography'}], 'secondaryOutcomes': [{'measure': 'Percent Primary Fecal Bile Acids', 'timeFrame': '48 hours', 'description': 'Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectrometry. Percent primary bile acids is then calculated as primary bile acids divided by total bile acids multiplied by 100.'}, {'measure': 'Stool Characteristics - Stool Frequency in 4 Days', 'timeFrame': '4 days', 'description': 'Stool characteristics will be measured using a 4 day bowel diary. Stool frequency is the total number of bowel movements in 4 days summarized on the subject level.'}, {'measure': 'Stool Characteristics - Stool Form', 'timeFrame': '4 days', 'description': 'Stool characteristics will be measured using a 4 day bowel diary. Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage,3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy,7=watery, summarized on the level of bowel movements.'}, {'measure': 'Stool Characteristics - Ease of Passage', 'timeFrame': '4 days', 'description': 'Stool characteristics will be measured using a 4 day bowel diary. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'microbiota', 'short chain fatty acids', 'prebiotic', 'bile acids'], 'conditions': ['IBS - Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.', 'detailedDescription': 'The Study involves 3 visits and will in include 3 types of subjects - those who have irritable bowel syndrome (IBS) with constipation (IBS-C), IBS with diarrhea (IBS-D) and those who have no IBS symptoms or diagnosis.\n\nVisit 1\n\n* Volunteers will read and sign this informed consent after all questions about the study have been answered\n* This is a screening visit and we may determine that volunteers ineligible to continue to participate in the study.\n* Volunteers will have a medical history taken including demographics, history of symptoms and illness\n* Volunteers will be asked about all medications\n* A physical exam will be performed by the physician.\n* Vital signs will be measured.\n* Urine Pregnancy test may be done for woman in the reproductive age range.\n* Eligible participants will be provided with a take-home lasagna meal.\n* Participants will be given instructions and supplies for collection, storage and transportation of stool for the next visit.\n* Participants will be provided with instructions for a low fiber, high fat diet which should be consumed for 2 days before stool collection and during the 2 days of stool collection. Instructions will also come with materials to allow participants to record diet intake during these 4 days.\n* Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study\n\nDay 1: this may be the same as Visit 1 or it may be a different day. It will depend upon the day that participants can make it back to the clinic for the Day 5 visit.\n\nDay 2-4 (at home):\n\n* Participants record stool symptoms and patterns in a diary daily starting from Day 2 to Day 5.\n* During this time, participants will be instructed to consume a low fiber diet, avoid alcohol, and start a 4-day 100 g fat diet.\n* On the evening before Day 5, a standardized, completely digestible, and non-fermentable meal (lasagna) will be consumed which will be provided to you on Day 1.\n* Participants will collect stool at home on Day 4 and 5 and store as per instructions provided on Visit 1. They will\n\nDay 5 (Visit 2):\n\n* Participants return to the clinic on Day 5 after an overnight fast.\n* You will receive a standard breakfast and lasanga meal with 10 g inulin (Orafti®) powder and 200 mL of water.\n* Take-home meals will be provided (white bread sandwich with ham or cheese) to be consumed at 4 and 8 hours after breakfast.\n\nDay 6 (Visit 3):\n\n* Participants will return to the clinic in order to return stool collections and the daily diaries.\n* Participants may also submit diaries by fax or email.\n\nDay 30-90\n\n• Optional dietary follow-up (Day 30-90): To further assess the utility of the 24 hour dietary recall, willing participants will be invited to participate in a an optional follow-up activity during which they will complete the Automated Self-Administered Dietary Assessment Tool with or without assistance of a trained interviewer. Interested volunteers will be contacted by phone and provided instructions on how to complete the tool online by the study team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.\n* Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.\n\nExclusion Criteria:\n\n* Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT \\> 2.0x the upper limit of normal\n* Prior radiation therapy of the abdomen or abdominal surgeries except for C-section, tubal ligation, vaginal hysterectomy and appendectomy or cholecystectomy, \\> 6 months prior to study initiation.\n* Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed.\n* Any females who are pregnant or trying to become pregnant or breast-feeding\n* Antibiotic usage within 3 months prior to study participation\n* Prebiotic or probiotic usage within the 2 weeks prior to study initiation\n* Regular use of tobacco products within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT03983434', 'briefTitle': 'Irritable Bowel Syndrome and Control Volunteers: Diet Challenge', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge', 'orgStudyIdInfo': {'id': '1903209172'}, 'secondaryIdInfos': [{'id': 'K23DK122015', 'link': 'https://reporter.nih.gov/quickSearch/K23DK122015', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'description': 'Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.', 'interventionNames': ['Dietary Supplement: Inulin']}, {'type': 'EXPERIMENTAL', 'label': 'Irritable Bowel Syndrome Patients with Diarrhea', 'description': 'Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS', 'interventionNames': ['Dietary Supplement: Inulin']}, {'type': 'EXPERIMENTAL', 'label': 'Irritable Bowel Syndrome Patients with Constipation', 'description': 'Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS', 'interventionNames': ['Dietary Supplement: Inulin']}], 'interventions': [{'name': 'Inulin', 'type': 'DIETARY_SUPPLEMENT', 'description': "Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.", 'armGroupLabels': ['Healthy volunteers', 'Irritable Bowel Syndrome Patients with Constipation', 'Irritable Bowel Syndrome Patients with Diarrhea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Huiping XU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Huiping Xu', 'investigatorAffiliation': 'Indiana University'}}}}