Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients

Launched by CHARLES UNIVERSITY, CZECH REPUBLIC · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of faecal bacteriotherapy, a treatment that involves using healthy bacteria from the stool of donors, to help critically ill patients who are experiencing diarrhea after taking antibiotics. Diarrhea in these patients can last a long time and can be challenging to treat, especially when it's caused by infections like Clostridium difficile. The goal of this study is to see if this treatment is safe and how well it works compared to standard treatments.

To participate in the trial, patients must be over 18 years old, currently in the ICU, and have had diarrhea for at least 24 hours after taking antibiotics. Patients who are close to death or have certain severe infections will not be eligible. Those who join the trial will receive either the new faecal bacteriotherapy treatment or the usual care for their diarrhea. The study will monitor how well the treatments work over a week and look at other health factors related to the patients' gut bacteria and overall response to the treatment. It's important to note that this trial is currently recruiting participants, and all potential participants will need to give informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • signing of informed consent (see below)
• • age \> 18 yrs.
• • in-patient in ICU or HDU (incl. burn unit) and expected to stay for \>7 days
• • 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.
• Exclusion Criteria:
• • death appears imminent or ceilings of care put in place
• • presence of new-onset sepsis defined as per 2016 definition
• • lactate \>2.0 mM, colon diameter \> 9 cm on plain AXR
• • the necessity of ongoing antibiotic treatment for another reasons
• • unable to tolerate enema for any reason (e.g. surgery of the GI tract in the past year)
• • pregnant and lactating woman
• • 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).