Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04401605
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2020-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fermented Food-Supplemented Diet in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'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': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the clinical disease activity inflammatory marker fecal calprotectin', 'timeFrame': 'Baseline (Data Collection 1) versus Week 10 (Data Collection 2).', 'description': 'Change in fecal calprotectin'}], 'secondaryOutcomes': [{'measure': 'Clinical response as per partial Mayo score.', 'timeFrame': 'Baseline (Data Collection 1) versus Week 10 (Data Collection 2).', 'description': 'Clinical response as per partial Mayo score is defined as a decrease from baseline in the partial Mayo Score of \\>=2 points and either a rectal bleeding subscore of \\<=1 or a decrease in the rectal bleeding subscore of \\>=1 point (assessed at Data Collection 2). The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy. Each subscore is graded from 0 to 3 (3 being the worst situation and 0 the best) and the partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).'}, {'measure': 'Clinical remission as per partial Mayo score.', 'timeFrame': 'Assessed at Week 10 (Data Collection 2).', 'description': 'Clinical remission as per partial Mayo score is defined as a partial Mayo score \\< 2 points and no individual subscale score \\>1 point (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).'}, {'measure': 'Symptomatic remission as per Patient Reported Outcome (PRO2) score', 'timeFrame': 'Assessed at Week 10 (Data Collection 2).', 'description': 'Symptomatic remission is defined as as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0 (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).'}, {'measure': 'Patient global assessment', 'timeFrame': 'Assessed at Week 10 (Data Collection 2).', 'description': '"Do you believe you are in remission from your UC symptoms?" (Yes/No)'}, {'measure': 'Effect of Fermented Food-Supplemented Diet on patient quality of life', 'timeFrame': 'Baseline (Data Collection 1) versus Week 10 (Data Collection 2).', 'description': 'Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score. The SIBDQ is a quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).'}, {'measure': 'Changes in cytokines/chemokines and immune cell profiles', 'timeFrame': 'Baseline (Data Collection 1) versus Week 10 (Data Collection 2).', 'description': 'Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.'}, {'measure': 'Changes in gut microbiome profiles', 'timeFrame': 'Baseline (Data Collection 1) versus Week 10 (Data Collection 2).', 'description': 'Gut microbiome profiles'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD', 'Ulcerative Colitis', 'UC', 'Diet', 'Fermented Food'], 'conditions': ['Inflammatory Bowel Diseases', 'Diet Modification', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Male or female subjects, ≥18 years of age\n* Confirmed diagnosis of UC\n* Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)\n* Elevated fecal calprotectin\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing or expect to be pregnant\n* Intolerance to fermented food\n* Individuals with a body mass index (BMI) lower than 18\n* Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)\n* Individuals who have been severely weakened by a disease or medical procedure\n* Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician\n* Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \\< 40%)\n* History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.\n\nComplications of disease such as extraintestinal manifestations (EIMs) are not automatically considered exclusion criteria. Appropriate medical treatment for UC and/or EIMs will not be withheld."}, 'identificationModule': {'nctId': 'NCT04401605', 'briefTitle': 'Fermented Food-Supplemented Diet in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effects of a Fermented Food-Supplemented on Patients with Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'IRB 55558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fermented Food-Supplemented Diet', 'description': 'Patients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks.', 'interventionNames': ['Other: Fermented Food-supplemented Diet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Regular Diet Control Arm', 'description': 'Patients in this arm will continue their regular diet throughout the 10 weeks of study with a maximum of 1 serving of fermented foods per day.', 'interventionNames': ['Other: Regular Diet']}], 'interventions': [{'name': 'Fermented Food-supplemented Diet', 'type': 'OTHER', 'description': 'Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.', 'armGroupLabels': ['Fermented Food-Supplemented Diet']}, {'name': 'Regular Diet', 'type': 'OTHER', 'description': 'No change in diet.', 'armGroupLabels': ['Regular Diet Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Touran Fardeen', 'role': 'CONTACT', 'email': 'tfardeen@stanford.edu'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Touran Fardeen', 'role': 'CONTACT', 'email': 'tfardeen@stanford.edu', 'phone': '6507367311'}], 'overallOfficials': [{'name': 'Sidhartha Sinha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine (Gastroenterology and Hepatology)', 'investigatorFullName': 'Sidhartha Ranjit Sinha', 'investigatorAffiliation': 'Stanford University'}}}}