Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT03819803
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2018-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation in aGvHD After ASCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GI-aGvHD remission', 'timeFrame': '90 days after first FMT', 'description': 'Sustained remission of GI-aGvHD (CR or PR)'}], 'secondaryOutcomes': [{'measure': 'GI-aGvHD remission', 'timeFrame': '45, 180 and 365 days after first FMT', 'description': 'Sustained remission of GI-aGvHD (CR or PR)'}, {'measure': 'Disease-free survival', 'timeFrame': '180 and 365 days after first FMT', 'description': 'GI-aGvHD free survival'}, {'measure': 'Recurrence of GI-GvHD', 'timeFrame': '365 days after remission', 'description': 'Recurrence of GI-GvHD'}, {'measure': 'Patient survival', 'timeFrame': '180 and 365 days after first FMT', 'description': 'Survival (death or alive)'}, {'measure': 'SUSAR (Suspected Unexpected Serious Adverse Reaction)', 'timeFrame': 'within 48 hours after a FMT', 'description': "Number of lethal or non-lethal SUSAR's"}, {'measure': 'SAE (Serious Adverse Event)', 'timeFrame': 'within 48 hours after a FMT', 'description': "Number of lethal or non-lethal SAE's"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graft Versus Host Disease in GI Tract']}, 'descriptionModule': {'briefSummary': 'Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.\n\nFecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.\n\nPatients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first episode of histologically confirmed, steroid-refractory GI-aGvHD\n* reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement\n* eligibility for repeated colonoscopic procedures\n* informed consent\n\nExclusion Criteria:\n\n* complications during a previous colonoscopy\n* recurrent episode of GI-aGvHD\n* lacking cardiopulmonary fitness for repeated colonoscopic procedures\n* septic infection\n* acute extraintestinal organ failure (excluding bone marrow)\n* mechanical ileus'}, 'identificationModule': {'nctId': 'NCT03819803', 'briefTitle': 'Fecal Microbiota Transplantation in aGvHD After ASCT', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'GI-aGvHD_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Steroid refractory GI-aGvHD', 'description': 'Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.\n\nIntervention: Fecal microbiota transplantation', 'interventionNames': ['Biological: Fecal microbiota transplantation']}], 'interventions': [{'name': 'Fecal microbiota transplantation', 'type': 'BIOLOGICAL', 'description': '200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum', 'armGroupLabels': ['Steroid refractory GI-aGvHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Walter Spindelboeck, DDr.', 'role': 'CONTACT', 'email': 'walter.spindelboeck@medunigraz.at', 'phone': '0043316385', 'phoneExt': '30195'}, {'name': 'Walter Spindelboeck, DDr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Neumeister, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christoph Högenauer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Walter DDr. Spindelboeck', 'role': 'CONTACT', 'email': 'walter.spindelboeck@medunigraz.at', 'phone': '0043 316 385 30195'}], 'overallOfficials': [{'name': 'Peter Prof. Dr. Neumeister', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Division of Hematology, Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}