Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-31 @ 8:51 PM
Study NCT ID:
NCT03812705
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2019-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-01-19', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '12 weeks within FMT', 'description': 'Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.'}], 'secondaryOutcomes': [{'measure': 'Time to response', 'timeFrame': '12 weeks within FMT', 'description': 'Time to response of acute gastrointestinal GVHD'}, {'measure': 'Duration of response', 'timeFrame': '12 weeks within FMT', 'description': 'Duration of response of acute gastrointestinal GVHD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allogeneic hematopoeitic stem cell transplantation', 'acute gastrointestinal graft versus host disease', 'fecal microbiome transplantation'], 'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200\\~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response. If patient's condition is not improved after the second FMT, ceasing FMT.", 'detailedDescription': "The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD).\n\nInclusion criteria:\n\n1. Age\\>= 14 yrs ≤60 yrs.\n2. Diagnosed with hematological diseases.\n3. Recipients of allogeneic peripheral blood stem cell transplantation.\n4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.\n5. ECOG score ≤2;\n6. signed consent form.\n\nExclusion criteria:\n\n1. Complicated with uncontrolled severe infection except intestine and colon.\n2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;\n3. Absolute neutrophil count (ANC) \\<0.5×10e9/L or platelet count (PLT) \\< 20×10e9/L\n4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.\n5. Participating other clinical trials.\n6. Pregnant women.\n\nTreatment:\n\n1. Stop antibiotics treatment 1 day before FMT;\n2. Fasting food 6 hours before FMT;\n3. Give Ondansetron intravenously 1 hour before FMT for vomiting prevention;\n4. Injection of 200\\~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;\n5. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response;\n6. If patient's condition is not improved after the second FMT, stop FMT.\n\nMajor endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT, including complete response and partial response.\n\nMinor endpoints:\n\n1. Time to response of acute gastrointestinal GVHD;\n2. Duration of response of acute gastrointestinal GVHD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\\>= 14 yrs ≤60 yrs.\n2. Diagnosed with hematological diseases.\n3. Recipients of allogeneic peripheral blood stem cell transplantation.\n4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.\n5. Eastern Cooperative Oncology Group (ECOG) score ≤2;\n6. Signed consent form.\n\nExclusion Criteria:\n\n1. Complicated with uncontrolled severe infection except intestine and colon.\n2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;\n3. Absolute neutrophil count (ANC) \\<0.5×10e9/L or platelet count (PLT) \\< 20×10e9/L\n4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.\n5. Participating other clinical trials.\n6. Pregnant women.'}, 'identificationModule': {'nctId': 'NCT03812705', 'acronym': 'FEMITGIGVHD', 'briefTitle': 'Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease', 'orgStudyIdInfo': {'id': 'SHSYXY-FMT-GVHD-2018002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fecal microbiome transplantation', 'description': "1. Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200\\~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;\n2. If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response;\n3. If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.", 'interventionNames': ['Biological: fecal microbiome transplantation']}], 'interventions': [{'name': 'fecal microbiome transplantation', 'type': 'BIOLOGICAL', 'description': '1. Stop antibiotics treatment 1 day before fecal microbiome transplantation;\n2. Fasting food 6 hours before fecal microbiome transplantation;\n3. Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention;\n4. Perform fecal microbiome transplantation under colonoscopy or gastroscopy;\n5. Perform up to 4 times if patient response;\n6. Stop if no response after twice fecal microbiome transplantation.', 'armGroupLabels': ['fecal microbiome transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Jiao Tong University Affilated First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Jiao Tong University Affilated Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Liping Wan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Liping Wan', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}