Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT06478602
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-02', 'unreleaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-12-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-06-23', 'studyFirstSubmitQcDate': '2024-06-23', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implications of fecal microbiota transplantation in modulating the effects of liver cirrhosis.', 'timeFrame': 'Up to 3 months', 'description': 'The transfer of microbiota could potentially influence hepatic fibrosis via the gut-liver axis, as well as other complications caused by cirrhosis such as encephalopathy, ascites etc.'}, {'measure': 'Implications of fecal microbiota transplantation in modulating the condition of other organs.', 'timeFrame': 'Up to 3 months', 'description': 'The transfer of microbiota could potentially modulate the function of other major organs in the body.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '38001930', 'type': 'BACKGROUND', 'citation': 'Boicean A, Birlutiu V, Ichim C, Brusnic O, Onisor DM. Fecal Microbiota Transplantation in Liver Cirrhosis. Biomedicines. 2023 Oct 30;11(11):2930. doi: 10.3390/biomedicines11112930.'}, {'pmid': '38732276', 'type': 'BACKGROUND', 'citation': 'Boicean A, Ichim C, Todor SB, Anderco P, Popa ML. The Importance of Microbiota and Fecal Microbiota Transplantation in Pancreatic Disorders. Diagnostics (Basel). 2024 Apr 23;14(9):861. doi: 10.3390/diagnostics14090861.'}, {'pmid': '37189634', 'type': 'BACKGROUND', 'citation': 'Boicean A, Birlutiu V, Ichim C, Anderco P, Birsan S. Fecal Microbiota Transplantation in Inflammatory Bowel Disease. Biomedicines. 2023 Mar 27;11(4):1016. doi: 10.3390/biomedicines11041016.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of liver cirrhosis according to current protocols.\n* Conscious and cooperative adult patients.\n\nExclusion Criteria:\n\n* Patients with hemodynamic and/or respiratory instability.\n* Patients with contraindications for colonoscopy or fecal transplantation.\n* Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi.\n* Associated oncological pathology.\n* Patients with other causes of severe immunodeficiencies.\n* Lack of compliance with the conditions imposed by the research project.\n* Patients who do not sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT06478602', 'briefTitle': 'Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Academic Emergency County Hospital Sibiu'}, 'officialTitle': 'Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'No: 3505/15.02.2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal microbiota transplantation (FMT) in patients with liver cirrhosis', 'description': 'The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.', 'interventionNames': ['Biological: Fecal microbiota transplantation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will include patients who will be monitored for their progress while receiving standard treatment.'}], 'interventions': [{'name': 'Fecal microbiota transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['Colonoscopy'], 'description': 'Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum.', 'armGroupLabels': ['Fecal microbiota transplantation (FMT) in patients with liver cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '550245', 'city': 'Sibiu', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Cristian Ichim, Resident Doctor', 'role': 'CONTACT', 'email': 'cristian.ichim@ulbsibiu.ro', 'phone': '0040771643848'}, {'name': 'Victoria Birlutiu, Prof. Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adrian Boicean, Prof. Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'County Clinical Emergency Hospital of Sibiu', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}], 'centralContacts': [{'name': 'Cristian Ichim, Resident Doctor', 'role': 'CONTACT', 'email': 'cristian.ichim@ulbsibiu.ro', 'phone': '0040771643848'}], 'overallOfficials': [{'name': 'Victoria Birlutiu, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'County Clinical Emergency Hospital of Sibiu'}, {'name': 'Adrian Boicean, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'County Clinical Emergency Hospital of Sibiu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study results will be made public and other researchers will be able to receive the anonymized database upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cristian Ichim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cristian Ichim', 'investigatorAffiliation': 'Academic Emergency County Hospital Sibiu'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-02', 'type': 'RELEASE'}, {'date': '2025-12-05', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Cristian Ichim, Principal Investigator, Academic Emergency County Hospital Sibiu'}}}}