Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-19 @ 11:05 PM
Study NCT ID:
NCT05218850
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Butyrate Therapy in Pediatric 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002087', 'term': 'Butyrates'}], 'ancestors': [{'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission of clinical disease', 'timeFrame': '12 weeks', 'description': 'pediatric ulcerative colitis activity index, remission is \\<10, mild disease 10-34, moderate 35-64, severe 65 or greater'}], 'secondaryOutcomes': [{'measure': 'improvement of inflammatory markers including ESR, CRP, Calprotectin', 'timeFrame': '12 weeks', 'description': 'normalization or at least improvement of inflammatory markers described above'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ulcerative colitis'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.', 'detailedDescription': 'butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 7-21 years, mild to moderate ulcerative colitis\n\nExclusion Criteria:\n\n* UC therapy within 4 weeks of study medication initiation\n* infectious colitis, -pregnancy'}, 'identificationModule': {'nctId': 'NCT05218850', 'briefTitle': 'The Use of Butyrate Therapy in Pediatric Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Butyrate Therapy in Hispanic Children With Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'CHLA-22-00049'}, 'secondaryIdInfos': [{'id': '161396', 'type': 'OTHER', 'domain': 'IND'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'open label intervention arm', 'description': 'Butyrate enemas will be administered once daily for twelve weeks.', 'interventionNames': ['Drug: Butyrate']}], 'interventions': [{'name': 'Butyrate', 'type': 'DRUG', 'otherNames': ['Butyrate enemas'], 'description': 'Butyrate enemas will be administered once a day for 12 weeks', 'armGroupLabels': ['open label intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sonia Michail, MD', 'role': 'CONTACT', 'email': 'sonia.michail@hotmail.com', 'phone': '323-361-1353'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Sonia Michail, MD', 'role': 'CONTACT', 'email': 'sonia.michail@hotmail.com', 'phone': '3233611353'}], 'overallOfficials': [{'name': 'Sonia Michail, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data can be shared upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sonia Michail, MD', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}