MedTrace Logo

Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients

NCT05430269 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-10

No results posted yet for this study

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.

Conditions

  • Diarrhea Caused by Drug
  • Clostridium Difficile Infections

Interventions

OTHER

Faecal bacteriotherapy (FBT)

Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.

OTHER

standard-of-care protocolised treatment of postantibiotic diarhea

standard-of-care protocolised treatment of postantibiotic diarhea

Sponsors & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    collaborator OTHER_GOV

  • Donatio Intensivistam Endowment Fund

    collaborator UNKNOWN

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2024-12-01
Completion
2025-07-01

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430269 on ClinicalTrials.gov