NCT05430269

Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-02-09
• Primary completion: 2024-12-01
• Completion: 2025-07-01
• First posted: 2022-06-24
• Last updated: 2023-02-10

Locations

2 sites across 1 country: Czechia