Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT04542018
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2020-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'singhpr@med.umich.edu', 'phone': '734-647-1191', 'title': 'Prashant Singh, MBBS', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'description': 'Participants were encouraged to contact the study team if they experienced adverse events and were provided with contact information in the informed consent document. The study team did not specifically ask participants about adverse events or search medical records for potential AEs. Therefore, while all data collected is reported below, participants could have chosen not to report adverse events they experienced.', 'eventGroups': [{'id': 'EG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\na low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 2, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\na low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intervention Recipients Who Did Not Complete the Trial', 'description': 'These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders".', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post-Vaccination Stomach Pain and Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lactulose Mannitol Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}], 'classes': [{'title': 'Baseline - Lactulose Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '512.5', 'groupId': 'OG000', 'lowerLimit': '99', 'upperLimit': '3456'}, {'value': '394.5', 'groupId': 'OG001', 'lowerLimit': '204', 'upperLimit': '1982'}]}]}, {'title': '4-Week - Lactulose Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '456.8', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '1568'}, {'value': '411', 'groupId': 'OG001', 'lowerLimit': '221.4', 'upperLimit': '992.5'}]}]}, {'title': 'Baseline - Mannitol Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41395', 'groupId': 'OG000', 'lowerLimit': '9600', 'upperLimit': '430100'}, {'value': '86820', 'groupId': 'OG001', 'lowerLimit': '79040', 'upperLimit': '207900'}]}]}, {'title': '4-Week - Mannitol Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37030', 'groupId': 'OG000', 'lowerLimit': '2704', 'upperLimit': '83356'}, {'value': '54825', 'groupId': 'OG001', 'lowerLimit': '11314', 'upperLimit': '500480'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h', 'unitOfMeasure': 'micrograms per ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected from "Intervention Recipients Who Did Not Complete The Trial" arm'}, {'type': 'SECONDARY', 'title': 'Changes in Epithelial Permeability - Tight Junction Gene Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}], 'classes': [{'title': 'Baseline - ZO-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.9', 'groupId': 'OG000', 'lowerLimit': '.1', 'upperLimit': '3.5'}, {'value': '.7', 'groupId': 'OG001', 'lowerLimit': '.1', 'upperLimit': '1'}]}]}, {'title': '4-week - ZO-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '.3', 'upperLimit': '4.8'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '.2', 'upperLimit': '3.2'}]}]}, {'title': 'Baseline - JAM-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '2.6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '1.3'}]}]}, {'title': '4-week - JAM-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '7.2'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.3'}]}]}, {'title': 'Baseline - Occludin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '1.1'}]}]}, {'title': '4-week - Occludin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '4.8'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.1'}]}]}, {'title': 'Baseline - Claudin-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '3.8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.7'}]}]}, {'title': '4-week - Claudin-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '3.7'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'Changes in tight junction (TJ) gene expression in colonic biopsies before and after low FODMAP diet Gene expression of Tight junction proteins were normalized to that of Glyceraldehyde 3-phosphate dehydrogenase (GAPDH).', 'unitOfMeasure': 'ratio of TJ proteins to GAPDH', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed for the "Intervention Recipients Who Did Not Complete The Trial" arm because those participants did not submit second sample.'}, {'type': 'SECONDARY', 'title': 'Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}], 'classes': [{'title': 'Baseline - ZO-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06579', 'groupId': 'OG000', 'lowerLimit': '0.008542', 'upperLimit': '0.3880'}, {'value': '0.03703', 'groupId': 'OG001', 'lowerLimit': '0.01876', 'upperLimit': '0.07138'}]}]}, {'title': '4-week - ZO-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07330', 'groupId': 'OG000', 'lowerLimit': '0.01938', 'upperLimit': '0.3061'}, {'value': '0.05063', 'groupId': 'OG001', 'lowerLimit': '0.04520', 'upperLimit': '0.07585'}]}]}, {'title': 'Baseline - JAM-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07493', 'groupId': 'OG000', 'lowerLimit': '0.01628', 'upperLimit': '0.2034'}, {'value': '0.08437', 'groupId': 'OG001', 'lowerLimit': '0.02690', 'upperLimit': '0.09409'}]}]}, {'title': '4-week - JAM-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09149', 'groupId': 'OG000', 'lowerLimit': '0.02220', 'upperLimit': '0.3186'}, {'value': '0.07267', 'groupId': 'OG001', 'lowerLimit': '0.05500', 'upperLimit': '0.09367'}]}]}, {'title': 'Baseline - Occludin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.623', 'groupId': 'OG000', 'lowerLimit': '0.6874', 'upperLimit': '16.95'}, {'value': '3.834', 'groupId': 'OG001', 'lowerLimit': '2.624', 'upperLimit': '9.378'}]}]}, {'title': '4-week - Occludin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.529', 'groupId': 'OG000', 'lowerLimit': '0.7352', 'upperLimit': '13.05'}, {'value': '5.533', 'groupId': 'OG001', 'lowerLimit': '2.724', 'upperLimit': '16.5'}]}]}, {'title': 'Baseline - Claudin-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.542', 'groupId': 'OG000', 'lowerLimit': '0.5603', 'upperLimit': '20.69'}, {'value': '10.40', 'groupId': 'OG001', 'lowerLimit': '7.514', 'upperLimit': '12.13'}]}]}, {'title': '4-week - Claudin-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.22', 'groupId': 'OG000', 'lowerLimit': '1.696', 'upperLimit': '17.38'}, {'value': '9.218', 'groupId': 'OG001', 'lowerLimit': '1.108', 'upperLimit': '20.86'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'Changes in Quantitative tight junction immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet\n\nData is reported as ratio of TJ proteins to NA-K ATPase.', 'unitOfMeasure': 'ratio of TJ proteins to NA-K ATPase', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed for the "Intervention Recipients Who Did Not Complete The Trial" arm because those participants did not submit second sample.'}, {'type': 'SECONDARY', 'title': 'Changes in Stool Microbiome - Alpha Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}], 'classes': [{'title': 'Baseline - Alpha Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '649.087', 'spread': '160.1794', 'groupId': 'OG000'}, {'value': '532.75', 'spread': '153.69', 'groupId': 'OG001'}]}]}, {'title': '4-week - Alpha Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '599.7391', 'spread': '159.1749', 'groupId': 'OG000'}, {'value': '608.5', 'spread': '182.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Changes in relative abundance of bacteria before and after low FODMAP diet. Alpha diversity was measured as number of Amplicon Sequence Variant (ASV) measured in the specimen.', 'unitOfMeasure': 'ASVs Observed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed for the "Intervention Recipients Who Did Not Complete the Trial" arm because participants did not submit necessary samples for analysis.'}, {'type': 'SECONDARY', 'title': 'Changes in Stool Microbiome - Beta Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03722', 'groupId': 'OG000'}, {'value': '-0.2708', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Changes in relative abundance of bacteria before and after low FODMAP diet. For the beta diversity, an analysis of similarities (ANOSIM)test based on Bray-Curtis distances is the best measure if the communities were different. The ANOSIM R statistic gives the scale of difference. ANOSIM R ranges from -1 to 1, where 1 means there is most interparticipant similarity within the group compared with between the different groups, and where -1 means there is least interparticipant similarity within the group compared with between the different groups. A value close to 0 indicates no significant difference between groups, meaning the dissimilarity is similar both within and between groups', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed for the "Intervention Recipients Who Did Not Complete the Trial" arm because participants did not submit necessary samples for analysis.\n\nSome participants in both analyzed arms did not provide samples of sufficient quality for analysis.'}, {'type': 'SECONDARY', 'title': 'Immunohistochemistry for Mast Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}], 'classes': [{'title': 'Baseline - Mast Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '42.5'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '27.2'}]}]}, {'title': '4-Week - Mast Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '25.8'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '24.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'Number of mast cells in sample after immunohistochemistry were counted.', 'unitOfMeasure': 'mast cell count per high power field', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was analyzed for "Intervention Recipients Who Did Not Complete the Trial", as they did not submit necessary samples.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\na low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\na low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}, {'id': 'OG002', 'title': 'Intervention Recipients Who Did Not Complete the Trial', 'description': 'These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders".'}], 'classes': [{'title': 'Baseline - Belly Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '63.7', 'spread': '6.4', 'groupId': 'OG002'}]}]}, {'title': '4-week - Belly Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.1', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '60.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.2', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '61.3', 'spread': '5', 'groupId': 'OG002'}]}]}, {'title': '4-week - Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.8', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '55.6', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'PROMIS scales of Belly pain (5a) and diarrhea (6a) will be administered to assess the severity of belly pain and diarrhea in our patients. PROMIS Belly pain questionnaire and PROMIS diarrhea questionnaire have five and six questions, respectively, which assess symptom severity on a 5 point Likert scale. 50 indicates the general population mean with a standard deviation of 10. Higher T-scores on these questionnaires refer to more severe gastrointestinal symptoms.\n\nPROMIS belly pain asks how often did you have belly pain, severity of belly pain, interference with activities, bothersomeness and discomfort.\n\nPROMIS diarrhea asks how many days did you have loose stools, interference with activities, bothersomeness, and how often you experience urgency.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the "Intervention Recipients who did not Complete the Trial" arm did not submit surveys at the 4-week point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'OG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.7', 'spread': '84.8', 'groupId': 'OG000'}, {'value': '235.4', 'spread': '72.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Measure Description: IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity.\n\nParticipants were separated into arms based on the change in their responses from baseline to 4 weeks.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they were sorted into the third arm and not included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\na low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'FG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks\n\na low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks\n\nParticipants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}, {'id': 'FG002', 'title': 'Intervention Recipients Who Did Not Complete the Trial', 'description': 'These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders".'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'All participants began the same 4-week Low FODMAP diet treatment. Once participants completed the 4-week intervention, they were categorized based on the changes in their IBSSS survey responses. Data was analyzed for each group separately. Participants who did not submit their IBSSS surveys after 4-weeks of treatment could not be placed in either group, submitted no data, and are not considered to have "completed" the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points.'}, {'id': 'BG001', 'title': 'Non-Responders', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points.'}, {'id': 'BG002', 'title': 'Intervention Recipients Who Did Not Complete the Trial', 'description': 'These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders".'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '44.6', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '32.2', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '38.6', 'spread': '11.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '46', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', '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': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)', 'classes': [{'categories': [{'measurements': [{'value': '334.2', 'spread': '81.36', 'groupId': 'BG000'}, {'value': '254.5', 'spread': '65.52', 'groupId': 'BG001'}, {'value': '303.6', 'spread': '113.1', 'groupId': 'BG002'}, {'value': '317.4', 'spread': '86.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity.\n\nParticipants were separated into arms based on the change in their responses from baseline to 4 weeks.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they are not included in the analysis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-08', 'size': 298052, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-03T14:26', 'hasProtocol': True}, {'date': '2020-09-24', 'size': 263446, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-24T12:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with diarrhea predominant IBS (IBS-D) will undergo 4 weeks of low FODMAP diet. Urine, blood, stool, and colon biopsies will be collected before and after the diet to assess changes in gut physiology.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2020-09-01', 'resultsFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-10', 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week', 'timeFrame': '4 weeks', 'description': 'Measure Description: IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity.\n\nParticipants were separated into arms based on the change in their responses from baseline to 4 weeks.'}], 'primaryOutcomes': [{'measure': 'Lactulose Mannitol Excretion', 'timeFrame': '4 weeks', 'description': 'Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h'}], 'secondaryOutcomes': [{'measure': 'Changes in Epithelial Permeability - Tight Junction Gene Expression', 'timeFrame': '4 weeks', 'description': 'Changes in tight junction (TJ) gene expression in colonic biopsies before and after low FODMAP diet Gene expression of Tight junction proteins were normalized to that of Glyceraldehyde 3-phosphate dehydrogenase (GAPDH).'}, {'measure': 'Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining', 'timeFrame': '4 weeks', 'description': 'Changes in Quantitative tight junction immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet\n\nData is reported as ratio of TJ proteins to NA-K ATPase.'}, {'measure': 'Changes in Stool Microbiome - Alpha Diversity', 'timeFrame': '4 weeks', 'description': 'Changes in relative abundance of bacteria before and after low FODMAP diet. Alpha diversity was measured as number of Amplicon Sequence Variant (ASV) measured in the specimen.'}, {'measure': 'Changes in Stool Microbiome - Beta Diversity', 'timeFrame': '4 weeks', 'description': 'Changes in relative abundance of bacteria before and after low FODMAP diet. For the beta diversity, an analysis of similarities (ANOSIM)test based on Bray-Curtis distances is the best measure if the communities were different. The ANOSIM R statistic gives the scale of difference. ANOSIM R ranges from -1 to 1, where 1 means there is most interparticipant similarity within the group compared with between the different groups, and where -1 means there is least interparticipant similarity within the group compared with between the different groups. A value close to 0 indicates no significant difference between groups, meaning the dissimilarity is similar both within and between groups'}, {'measure': 'Immunohistochemistry for Mast Cells', 'timeFrame': '4 weeks', 'description': 'Number of mast cells in sample after immunohistochemistry were counted.'}, {'measure': 'Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': '4 weeks', 'description': 'PROMIS scales of Belly pain (5a) and diarrhea (6a) will be administered to assess the severity of belly pain and diarrhea in our patients. PROMIS Belly pain questionnaire and PROMIS diarrhea questionnaire have five and six questions, respectively, which assess symptom severity on a 5 point Likert scale. 50 indicates the general population mean with a standard deviation of 10. Higher T-scores on these questionnaires refer to more severe gastrointestinal symptoms.\n\nPROMIS belly pain asks how often did you have belly pain, severity of belly pain, interference with activities, bothersomeness and discomfort.\n\nPROMIS diarrhea asks how many days did you have loose stools, interference with activities, bothersomeness, and how often you experience urgency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '40749856', 'type': 'DERIVED', 'citation': 'Gao J, Lee AA, Abtahi S, Turner JR, Grover M, Schmidt A, Schmidt TM, Nee JW, Iturrino J, Lembo A, Chey WD, Wiley JW, Singh P. Low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet Improves Colonic Barrier Function and Mast Cell Activation in Patients With Diarrhea-Predominant Irritable Bowel Syndrome: A Mechanistic Trial. Gastroenterology. 2025 Jul 30:S0016-5085(25)05771-3. doi: 10.1053/j.gastro.2025.07.016. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms.\n* Normal stool studies including, ova and parasites since the onset of symptoms\n* IBS-SSS score of ≥175 at the end of the 7-day screening period\n\nIn case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.\n\nExclusion criteria\n\n* individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months\n* individuals with any known food allergy or insulin-dependent diabetes\n* known history of celiac disease, inflammatory bowel disease or microscopic colitis\n* prior small bowel or colonic surgery or cholecystectomy\n* pregnant patients\n* Antibiotics in the past 3 months\n* Those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.'}, 'identificationModule': {'nctId': 'NCT04542018', 'briefTitle': 'Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'HUM00166423'}, 'secondaryIdInfos': [{'id': 'K23DK129327', 'link': 'https://reporter.nih.gov/quickSearch/K23DK129327', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study patients with IBS-D', 'description': 'Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks', 'interventionNames': ['Other: a low FODMAP diet for 4 weeks']}], 'interventions': [{'name': 'a low FODMAP diet for 4 weeks', 'type': 'OTHER', 'description': 'low FODMAP diet for 4 weeks', 'armGroupLabels': ['Study patients with IBS-D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Prashant Singh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Prashant Singh', 'investigatorAffiliation': 'University of Michigan'}}}}