Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-17 @ 6:56 PM
Study NCT ID:
NCT02249169
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2014-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, serum, whole blood, stool, colonic mucosal tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months', 'timeFrame': 'baseline, 6 months', 'description': 'Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. This information will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in IBS, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Motility Clinic, Clinical Research Unit, GI Department', 'healthyVolunteers': True, 'eligibilityCriteria': 'IBS-C and IBS-D SUBJECTS:\n\nInclusion Criteria:\n\n* Clinical diagnosis of IBS-C or IBS-D\n* Age 18 to 65\n\nExclusion Criteria:\n\n* Prior history of abdominal surgeries (except appendectomy and cholecystectomy)\n* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition\n* Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)\n* Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy\n* Bowel preparation for colonoscopy within the past week\n* Pregnancy or plans to become pregnant within the study time frame\n* Vulnerable adults\n* Age greater than or equal to 66\n* Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes\n\nHEALTHY SUBJECTS:\n\nInclusion Criteria:\n\n* Age 18 to 65\n* No clinical diagnosis of IBS-C or IBS-D\n\nExclusion Criteria:\n\n* Prior history of abdominal surgeries (except appendectomy and cholecystectomy)\n* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition\n* Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)\n* Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy\n* Bowel preparation for colonoscopy within the past week\n* Pregnancy or plans to become pregnant within the study time frame\n* Vulnerable adults\n* Age greater than or equal to 66\n* Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes\n* Clinical diagnosis of IBS-C or IBS-D'}, 'identificationModule': {'nctId': 'NCT02249169', 'briefTitle': 'Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '14-000305'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBS-C', 'description': 'Patients with a clinical diagnosis of constipation-predominant irritable bowel syndrome'}, {'label': 'IBS-D', 'description': 'Patients with a clinical diagnosis of diarrhea-predominant irritable bowel syndrome'}, {'label': 'Healthy subjects', 'description': 'Subjects without a clinical diagnosis of IBS-C or IBS-D'}, {'label': 'Healthy Controls', 'description': 'Subject without a clinical diagnosis of IBS-C or IBS-D and who is either a first-degree relative of an IBS participant or is not genetically related but resides with the IBS participant'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Purna C. Kashyap, M.B.B.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Purna C. Kashyap, MBBS', 'investigatorAffiliation': 'Mayo Clinic'}}}}