Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-21 @ 1:20 AM
Study NCT ID:
NCT05321758
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2022-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D007166', 'term': 'Immunosuppressive Agents'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Partial enteral nutrition,FMT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'gut microbial', 'timeFrame': 'before treatment and 5-10 weeks after treatment', 'description': 'Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.'}], 'primaryOutcomes': [{'measure': 'Clinical remission', 'timeFrame': '8-12 weeks after FMT', 'description': "Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10"}, {'measure': 'Endoscopic remission', 'timeFrame': '8-12 weeks after FMT', 'description': 'Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2'}, {'measure': 'Mucosal healing', 'timeFrame': '8-12 weeks after FMT', 'description': 'Mucosal healing defined as SES-CD = 0'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '2 and 10 weeks after FMT', 'description': 'All possible adverse events:fever,abdominal pain,infectious diseases and others'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Crohn Disease;fecal microbiota transplantation'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '40050917', 'type': 'DERIVED', 'citation': "Zou B, Liu S, Dong C, Shen H, Lv Y, He J, Li X, Ruan M, Huang Z, Shu S. Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial. J Transl Med. 2025 Mar 6;23(1):288. doi: 10.1186/s12967-024-05832-1."}]}, 'descriptionModule': {'briefSummary': "To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.", 'detailedDescription': "Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of \\>10 and ≤40, and SES-CD of \\>3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy\n\nExclusion Criteria:\n\npatients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment'}, 'identificationModule': {'nctId': 'NCT05321758', 'acronym': 'FMT', 'briefTitle': "Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': "Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease", 'orgStudyIdInfo': {'id': '83663594'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FMT group', 'description': 'Repeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.', 'interventionNames': ['Biological: Fecal Microbiota Transplantation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Immunosuppressive group', 'description': 'Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment.', 'interventionNames': ['Drug: Immunosuppressive Agents']}], 'interventions': [{'name': 'Fecal Microbiota Transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['FMT'], 'description': 'In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.', 'armGroupLabels': ['FMT group']}, {'name': 'Immunosuppressive Agents', 'type': 'DRUG', 'otherNames': ['Immunosuppressive group'], 'description': 'hormones, azathioprine, thalidomide', 'armGroupLabels': ['Immunosuppressive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Biao Zou', 'role': 'CONTACT', 'email': '464021552@qq.com', 'phone': '15871365900'}, {'name': 'Sainan Shu', 'role': 'CONTACT', 'email': 'shusainan@163.com', 'phone': '13886011908'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Biao Zou, MD', 'role': 'CONTACT', 'email': '464021552@qq.com', 'phone': '15871365900'}, {'name': 'Sainan Shu, MD, PhD', 'role': 'CONTACT', 'email': 'shusainan@163.com', 'phone': '13886011908'}], 'overallOfficials': [{'name': 'Zhihua Huang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending physician', 'investigatorFullName': 'Biao Zou', 'investigatorAffiliation': 'Tongji Hospital'}}}}