Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-05 @ 7:17 PM
Study NCT ID:
NCT06495658
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Prebiotics in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056692', 'term': 'Prebiotics'}], 'ancestors': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The investigator and outcomes assessor will not be aware of participants' assignments."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-07-07', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response', 'timeFrame': 'Week 8', 'description': 'Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).'}, {'measure': 'Microbial composition', 'timeFrame': 'Week 8', 'description': 'Microbial composition includes a measurement and characterization of the relative quantity of genera and species.'}], 'secondaryOutcomes': [{'measure': 'Clinical remission', 'timeFrame': 'Week 8', 'description': 'Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \\< 4. Range of SCCAI is 0-20 (higher is more severe).'}, {'measure': 'Clinical response', 'timeFrame': 'Week 16', 'description': 'Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).'}, {'measure': 'Clinical remission', 'timeFrame': 'Week 16', 'description': 'Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \\< 4. Range of SCCAI is 0-20 (higher is more severe).'}, {'measure': 'Microbial composition', 'timeFrame': 'Week 16', 'description': 'Microbial composition includes a measurement and characterization of the relative quantity of genera and species.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.\n\nDietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 to 85 years old\n* History of biopsy-proven ulcerative colitis (UC)\n* Active symptoms (SCCAI \\>2)\n* Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.\n* Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.\n* Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial\n\nExclusion Criteria:\n\n* Prior colectomy\n* Hospitalization\n* Urgent need for abdominal surgery\n* Unstable major medical condition\n* Active malignancy under treatment\n* Active alcohol or non-cannabinoid substance abuse\n* Pregnancy or lactation\n* Concerns for non-compliance'}, 'identificationModule': {'nctId': 'NCT06495658', 'briefTitle': 'Impact of Prebiotics in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis', 'orgStudyIdInfo': {'id': '24-000256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prebiotic at Week 0', 'interventionNames': ['Dietary Supplement: Prebiotic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prebiotic at Week 8', 'interventionNames': ['Dietary Supplement: Prebiotic']}], 'interventions': [{'name': 'Prebiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.', 'armGroupLabels': ['Prebiotic at Week 0', 'Prebiotic at Week 8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Berkeley Limketkai, MD, PhD', 'role': 'CONTACT', 'email': 'berkeley.limketkai@gmail.com', 'phone': '8554238252'}], 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Berkeley Limketkai, MD, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}