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| Name | Class |
|---|---|
| Faculty Hospital Kralovske Vinohrady | OTHER_GOV |
| Donatio Intensivistam Endowment Fund | UNKNOWN |
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Rationale: Postantibiotic diarrhoea in critically ill patients is common, often prolonged and currently there is no effective treatment of it.
Aim: To test safety and feasibility of faecal microbial transplantation in critically ill patients with postantibiotic diarhoea.
Design: 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.
Treatment 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.
Control 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).
Primary 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.
Secondary 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | ICU patients who developed diarhea after a course of antibiotic therapy treated with Faecal bacteriotherapy (FBT) delivered as enema |
|
| Control group | Active Comparator | ICU patients who developed diarhea after a course of antibiotic therapy treated standard-of-care protocolised treatment of postantibiotic diarhea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faecal bacteriotherapy (FBT) | Other | Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | 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 | 7 days after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of therapeutic efficacy | Difference of proportion of patients between intervention and control groups who are diarhoea-free (WHO definition) | 7 days after randomisation |
| Systemic inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kralovske Vinohrady University Hospital | Recruiting | Prague | 10034 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39729440 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2021 | Apr 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2022 | Apr 21, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Prospective, single center, parallel group randomised controlled trial.
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| standard-of-care protocolised treatment of postantibiotic diarhea | Other | standard-of-care protocolised treatment of postantibiotic diarhea |
|
Difference between intervention and control group in area under C-reactive protein plasma concentration curve
| 7 days after randomisation |
| Organ failures | Difference between intervention and control group in SOFA score curve | 7 days after randomisation |
| Postprocedural bacteriaemia | Difference between intervention and control group in the percentage of positive blood cultures | 3 hours after intervention |
| Mortality | Difference between intervention and control group in the absolute risk of death (intention-to-treat analysis) | 28 day or hospital discharge, whichever occurs earlier |
| František Duška | Recruiting | Prague | Česká Republika | 10034 | Czechia |
|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |