Clinical Trials Logo
  1. Home
  2. Clostridium Difficile Infections
  3. NCT05430269

Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients — FEBATRICE  

Clostridium Difficile Infections Clinical Trial

Official title:
Faecal Bacteriotherapy for Antibiotic-Associated Diarrhoea in Patients In Intensive Care - Randomised Controlled Trial

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05430269
Study type Interventional
Source Charles University, Czech Republic
Contact
Status Recruiting
Phase N/A
Start date February 9, 2023
Completion date July 1, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06030245 - Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance
Completed NCT01957761 - Molecular Epidemiology of Clostridium Difficile Infections in Children N/A
Recruiting NCT05714566 - Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients
Recruiting NCT06237452 - VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 3
Not yet recruiting NCT06107569 - Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma Phase 3
Not yet recruiting NCT06398379 - Virus as Treatment of C. Difficile Infection (VISION) N/A
Not yet recruiting NCT05256693 - Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant Phase 3
Recruiting NCT06311006 - Safety Registry of a Fecal Microbiota Transplant Cohort