Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT04711967
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2020-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2020-12-30', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in times of stool', 'timeFrame': 'day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.', 'description': 'Change in times of stool per day within 28 days after FMT'}, {'measure': 'change in volume of stool', 'timeFrame': 'day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.', 'description': 'Change in volume of stool per day within 28 days after FMT'}], 'secondaryOutcomes': [{'measure': 'Change in life quality up to 28 days', 'timeFrame': 'day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.', 'description': 'The change quality of patients life within 28 days after FMT is assessed by "EORTC Quality of Life measurement Scale QLQ-C30 (V3.0)" with a score ranged 0\\~100. And the higher the score, the better the functional status and quality of life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute-graft-versus-host Disease', 'Fecal microbiota transplantation'], 'conditions': ['Acute Graft Versus Host Disease in Intestine']}, 'descriptionModule': {'briefSummary': 'Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.', 'detailedDescription': 'Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. received allo-HSCT due to a hematopoietic disease\n2. corticosteroid resistant/dependent intestinal GVHD\n3. ECOG≤2\n4. Sign informed Consent\n5. No major organ dysfunction\n\nExclusion Criteria:\n\n1. uncontrolled or severe infections\n2. patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder\n3. high-risk bleeding\n4. ANC\\<0.5×10\\^9/L or PLT\\<20x10\\^9/L\n5. hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease\n6. patients participating in other clinical trials\n7. patienta who suffer from mental illness'}, 'identificationModule': {'nctId': 'NCT04711967', 'briefTitle': 'Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '2020SDUCRCC015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal Microbiota Transplantation group', 'description': 'treat with FMT', 'interventionNames': ['Biological: Fecal Microbiota Transplantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'treat with traditional medicine', 'interventionNames': ['Drug: drug']}], 'interventions': [{'name': 'Fecal Microbiota Transplantation', 'type': 'BIOLOGICAL', 'description': 'fecal microbiota transplantation', 'armGroupLabels': ['Fecal Microbiota Transplantation group']}, {'name': 'drug', 'type': 'DRUG', 'description': 'drug', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meng p Lv', 'role': 'CONTACT', 'phone': '13701140918'}], 'facility': "Peking university people's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuqian Xu, Ph. D, M. D.', 'role': 'CONTACT', 'email': 'shuqian.xu@email.sdu.edu.cn', 'phone': '18560087013'}], 'facility': 'Shandong university qilu hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Shuqian Xu', 'role': 'CONTACT', 'email': 'shuqian.xu@email.sdu.edu.cn', 'phone': '+86 0531-88382169'}], 'overallOfficials': [{'name': 'Shuqian Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': "Peking University People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}