Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT04758806
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2021-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Eligible for the study are consecutive consenting adult patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28-day', 'description': 'Overall mortality'}, {'measure': 'Mortality', 'timeFrame': '90-day', 'description': 'Overall mortality'}, {'measure': 'Mortality', 'timeFrame': '1 year', 'description': 'Overall mortality'}], 'secondaryOutcomes': [{'measure': 'Acute on chronic liver failure', 'timeFrame': 'In-Hospital', 'description': 'Acute on chronic liver failure by European definition'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcoholic hepatitis', 'Nonresponders', 'fecal microbial transplantation'], 'conditions': ['Alcoholic Hepatitis']}, 'descriptionModule': {'briefSummary': '1. A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019)\n2. The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial)\n3. New treatment modalities for remaining patients are much needed\n4. Fecal microbial transplantation (FMT) is one of the promising therapies\n5. Investigators aimed to see if FMT improves survival in patients admitted with SAH, not responding to-, or non-eligible for CS.', 'detailedDescription': '* FMT via upper GI tract is provided to CS non-responders (NR) or non-eligible (NE) adult patients hospitalized with SAH (determined by the Lille-model).\n* Modified version of the Sarin FMT protocol is used with microbiota material procured from unrelated healthy donors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consenting, adult\n* severe form of acute alcoholic hepatitis (SAH)\n* non-responder to corticosteroids according to the Lille model\n* patients with SAH not eligible for corticosteroids based on their contraindications\n\nExclusion Criteria:\n\n* active infection\n* presence of untreated large / high-risk / bleeding esophageal varices\n* too sick for any therapy / futility (chronic extrahepatic organ failures, no potential for recovery, etc)\n* malignancy except for hepatocellular carcinoma in Milan criteria'}, 'identificationModule': {'nctId': 'NCT04758806', 'acronym': 'FMTH7', 'briefTitle': 'Fecal Microbial Transplantation in Severe Alcoholic Hepatitis', 'organization': {'class': 'OTHER', 'fullName': 'F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica'}, 'officialTitle': 'Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis', 'orgStudyIdInfo': {'id': '432/2018-IK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal microbial transplantation from unrelated donor', 'description': 'Fecal microbial transplant procured (frozen if needed) from healthy unrelated donors is administered via upper GI tract; predefined single dose is repeated at five consecutive days', 'interventionNames': ['Biological: Fecal microbial transplantation']}], 'interventions': [{'name': 'Fecal microbial transplantation', 'type': 'BIOLOGICAL', 'description': 'Procured faeces procured from unrelated donor', 'armGroupLabels': ['Fecal microbial transplantation from unrelated donor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Banská Bystrica', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Lubomir Skladany, MD, PhD', 'role': 'CONTACT', 'email': 'lubomir.skladany@gmail.com', 'phone': '+421905482997'}, {'name': 'Natalia Bystrianska, MD', 'role': 'CONTACT', 'email': 'naty2121@centrum.sk', 'phone': '+421917944393'}, {'name': 'Daniela Jancekova, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Janka Vnencakova, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'F.D.Roosevelt Teaching Hospital', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}], 'centralContacts': [{'name': 'Lubomir Skladany, MD,PhD', 'role': 'CONTACT', 'email': 'lubomir.skladany@gmail.com', 'phone': '+421905482997'}, {'name': 'Natalia Bystrianska, MD', 'role': 'CONTACT', 'email': 'naty2121@centrum.sk', 'phone': '+421917944393'}], 'overallOfficials': [{'name': 'Lubomir Skladany, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia'}]}, 'ipdSharingStatementModule': {'url': 'http://www.fnspfdr.sk', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'First release of results is expected in 2021, final analysis in 2022', 'ipdSharing': 'YES', 'description': 'On request by institution of interest, e.g. on submission to medical journal / by editorial office; by auditing authority', 'accessCriteria': 'General Data Protection Regulation (GDPR) compliance Editorial office approved member Auditing authority Authors, meta analysis / systematic review'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator', 'investigatorFullName': 'Ľubomír Skladaný MD, PhD', 'investigatorAffiliation': 'F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica'}}}}