Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-01 @ 2:48 PM
Study NCT ID:
NCT05430269
Status:
UNKNOWN
Last Update Posted:
2023-02-10
First Post:
2022-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-22', 'size': 417261, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-21T09:59', 'hasProtocol': True}, {'date': '2022-04-22', 'size': 198704, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-21T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, single center, parallel group randomised controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2022-04-03', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure', 'timeFrame': '7 days after randomisation', 'description': 'Difference of proportion of patients between intervention and control groups in whom the treatment failed. Failure is defined as treatment has either not been delivered or has not been effective to cure diarrhoea as per WHO definition'}], 'secondaryOutcomes': [{'measure': 'Comparison of therapeutic efficacy', 'timeFrame': '7 days after randomisation', 'description': 'Difference of proportion of patients between intervention and control groups who are diarhoea-free (WHO definition)'}, {'measure': 'Systemic inflammation', 'timeFrame': '7 days after randomisation', 'description': 'Difference between intervention and control group in area under C-reactive protein plasma concentration curve'}, {'measure': 'Organ failures', 'timeFrame': '7 days after randomisation', 'description': 'Difference between intervention and control group in SOFA score curve'}, {'measure': 'Postprocedural bacteriaemia', 'timeFrame': '3 hours after intervention', 'description': 'Difference between intervention and control group in the percentage of positive blood cultures'}, {'measure': 'Mortality', 'timeFrame': '28 day or hospital discharge, whichever occurs earlier', 'description': 'Difference between intervention and control group in the absolute risk of death (intention-to-treat analysis)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiota', 'critically ill', 'fecal microbial transplantation'], 'conditions': ['Diarrhea Caused by Drug', 'Clostridium Difficile Infections']}, 'referencesModule': {'references': [{'pmid': '39729440', 'type': 'DERIVED', 'citation': 'Cibulkova I, Rehorova V, Soukupova H, Waldauf P, Cahova M, Manak J, Matejovic M, Duska F. Allogenic faecal microbiota transplantation for antibiotic-associated diarrhoea in critically ill patients (FEBATRICE)-Study protocol for a multi-centre randomised controlled trial (phase II). PLoS One. 2024 Dec 27;19(12):e0310180. doi: 10.1371/journal.pone.0310180. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Postantibiotic diarrhoea in critically ill patients is common, often prolonged and currently there is no effective treatment of it.\n\nAim: To test safety and feasibility of faecal microbial transplantation in critically ill patients with postantibiotic diarhoea.\n\nDesign: Prospective, single center, parallel group randomised controlled trial. Subjects: ICU patients (both general and burn ICU) who developed diarhea after a course of antibiotic therapy that is persistent for 24 hours and is not due to other causes. Patients with septic shock or approaching death will be excluded.\n\nTreatment in the intervention group: Faecal bacteriotherapy (FBT) delivered as enema (and repeated once in the subgroup of patients with C. dif. infection) of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.\n\nControl group: Standard-of-care protocolised treatment of postantibiotic diarhea (which includes vancomycine 250 mg p.o. 6 hourly in the subgroup with C. dif. infection).\n\nPrimary outcome: Percentage of patients with treatment failure at day 7 after randomisation, which is defined as treatment either not being delivered or not being effective.\n\nSecondary and exploratory outcomes: Influence of the intervention on colonic microbiome and metabolome, small bowel and colonic permeability, bacterial translocation and systemic inflammation response to procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signing of informed consent (see below)\n* age \\> 18 yrs.\n* in-patient in ICU or HDU (incl. burn unit) and expected to stay for \\>7 days\n* diarrhea following antibiotic treatment defined as 3 or more stools per day or Bristol type 7 stool in the volume \\>300 ml/day if stool derivative device is in place, persisting for 24 hours despite enteral feeding formula has been stopped.\n\nExclusion Criteria:\n\n* death appears imminent or ceilings of care put in place\n* presence of new-onset sepsis defined as per 2016 definition\n* lactate \\>2.0 mM, colon diameter \\> 9 cm on plain AXR\n* the necessity of ongoing antibiotic treatment for another reasons\n* unable to tolerate enema for any reason (e.g. surgery of the GI tract in the past year)\n* pregnant and lactating woman\n* patients with a history of severe anaphylactic food allergy, any other reason which - as per judgement of the treating clinician - makes faecal transplantation unsafe or not feasible (Note: All screening failures based on this criterion will be reported separately, inc. the reason why it was considered unsafe or not feasible to proceed).'}, 'identificationModule': {'nctId': 'NCT05430269', 'acronym': 'FEBATRICE', 'briefTitle': 'Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Faecal Bacteriotherapy for Antibiotic-Associated Diarrhoea in Patients In Intensive Care - Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2021-002290-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'ICU patients who developed diarhea after a course of antibiotic therapy treated with Faecal bacteriotherapy (FBT) delivered as enema', 'interventionNames': ['Other: Faecal bacteriotherapy (FBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'ICU patients who developed diarhea after a course of antibiotic therapy treated standard-of-care protocolised treatment of postantibiotic diarhea', 'interventionNames': ['Other: standard-of-care protocolised treatment of postantibiotic diarhea']}], 'interventions': [{'name': 'Faecal bacteriotherapy (FBT)', 'type': 'OTHER', 'description': 'Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.', 'armGroupLabels': ['Intervention group']}, {'name': 'standard-of-care protocolised treatment of postantibiotic diarhea', 'type': 'OTHER', 'description': 'standard-of-care protocolised treatment of postantibiotic diarhea', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10034', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Frantisek Duska', 'role': 'CONTACT', 'email': 'frantisek.duska@fnkv.cz', 'phone': '+420267162451'}], 'facility': 'Kralovske Vinohrady University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '10034', 'city': 'Prague', 'state': 'Česká Republika', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'František Duška', 'role': 'CONTACT', 'email': 'fduska@yahoo.com', 'phone': '608405541'}], 'facility': 'František Duška', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faculty Hospital Kralovske Vinohrady', 'class': 'OTHER_GOV'}, {'name': 'Donatio Intensivistam Endowment Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'František Duška, MD, PhD, A/Prof, AFICM, EDIC', 'investigatorFullName': 'Frantisek Duska, MD, PhD', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}