Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 5:27 AM
Study NCT ID:
NCT04121806
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2019-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet Intervention Treatment for Active Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in microbiome composition', 'timeFrame': '10 weeks', 'description': 'measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual'}, {'measure': 'Change in microbiome function', 'timeFrame': '10 weeks', 'description': 'measured by shotgun sequencing and comparing difference in enriched functional pathways between pretreatment diet and the treatment diet within an individual'}], 'secondaryOutcomes': [{'measure': 'Decrease in endoscopic disease activity', 'timeFrame': '10 weeks', 'description': 'measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual'}, {'measure': 'Decrease in clinical disease activity', 'timeFrame': '10 weeks', 'description': 'measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colitis, Ulcerative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.', 'detailedDescription': 'The etiology of inflammatory bowel disease (IBD), including ulcerative colitis (UC), is complex and poorly understood, but the current hypothesis is that IBD arises from an aberrant immune response to commensal bacteria in a genetically susceptible host, and is triggered by environmental factors. Environmental factors such as the microbiome and diet, play a significant role in the risk of IBD. Diet has been identified as one of the main drivers of the microbiome composition and the microbiome and diet can work in tandem to affect host physiology.\n\nIn spite of patient interest in diet and numerous diet studies, currently there is no diet that is clinically validated or universally agreed upon for adult IBD patients. We also lack rigorous studies to show how the microbiome is influenced by diet and affects patient outcomes.\n\nWe propose to use a sustainable non-elemental diet aimed at altering the microbiome in patients with mild to moderately active UC to alter their disease activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Females and Males between the ages of 18 - 75 years of age at the time of enrolment\n\n * Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria\n * Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment\n * Must have had \\> 10cm involvement at some point in their disease history\n * FCP\\>250 or active endo within 6 months\n * If a smoker, must not change smoking habits (frequency) during the course of the study\n * If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study\n\nExclusion Criteria:\n\n* • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment\n\n * Pregnant or lactating females\n * Allergy or intolerance to key or a great number food components of the study diet\n * Current NSAID use\n * Diagnosed with PSC\n * Using topical therapies or suppositories\n * Antibiotic use within 4 weeks of the study enrollment or during the study\n * Confirmed C. difficile infection within 3 months of recruitment;\n * Diagnosis of primary PSC;\n * Currently using topical therapies or suppositories\n * History of dysplasia or colorectal neoplasia.'}, 'identificationModule': {'nctId': 'NCT04121806', 'briefTitle': 'Diet Intervention Treatment for Active Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': '19-0112-A'}, 'secondaryIdInfos': [{'id': '3U01DK062423-18S1', 'link': 'https://reporter.nih.gov/quickSearch/3U01DK062423-18S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ulcerative colitis patients with mild to moderate activity', 'description': 'Participants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet.', 'interventionNames': ['Other: UC intervention diet']}], 'interventions': [{'name': 'UC intervention diet', 'type': 'OTHER', 'description': 'The treatment diet has been designed based on the literature with the goal of influencing the biodiversity and density of the microbiome. All food through the duration of the 8 week dietary intervention period of the study will be provided to the treatment arm study participants.', 'armGroupLabels': ['Ulcerative colitis patients with mild to moderate activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jenny Lee', 'role': 'CONTACT', 'email': 'jenny.lee@sinaihealth.ca', 'phone': '4165864800', 'phoneExt': '2318'}, {'name': 'Mark S Silverberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Jenny Lee', 'role': 'CONTACT', 'email': 'jenny.lee@sinaihealth.ca', 'phone': '4165864800', 'phoneExt': '2318'}, {'name': 'Joanne Stempak', 'role': 'CONTACT', 'email': 'joanne.stempak@sinaihealth.ca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study results or individual subject results such as investigational tests will not be shared with the research participants or others unless deemed medically necessary. Result of this research and management of intellectual property will adherence to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources issued March 5, 2003.\n\nPublication of data during the project and/or at the end of the project shall be consistent with normal scientific practices. Research data which documents, supports, and validates research findings will be made available after the main findings from the final research data set have been accepted for publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}