Fecal transplant for diarrhea after antibiotics in critically ill patients
Faecal Bacteriotherapy for Antibiotic-Associated Diarrhoea in Patients In Intensive Care - Randomised Controlled Trial
NA · Charles University, Czech Republic · NCT05430269
This study is testing if a fecal transplant can help critically ill patients who have diarrhea after taking antibiotics feel better compared to standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic (other) |
| Locations | 2 sites (Prague and 1 other locations) |
| Trial ID | NCT05430269 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of fecal microbial transplantation (FMT) in critically ill patients suffering from postantibiotic diarrhea. It is a prospective, single-center, parallel group randomized controlled trial involving ICU patients who have developed persistent diarrhea following antibiotic treatment. Participants will receive either FMT delivered as an enema or standard-of-care treatment for their condition. The study focuses on patients with diarrhea not caused by other factors and excludes those with severe underlying conditions.
Who should consider this trial
Good fit: Ideal candidates are ICU patients over 18 years old who have persistent diarrhea following antibiotic therapy.
Not a fit: Patients who are nearing death, have new-onset sepsis, or cannot tolerate an enema will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective solution for managing postantibiotic diarrhea in critically ill patients.
How similar studies have performed: Other studies have shown promise in using fecal microbiota transplantation for various gastrointestinal conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Prague and 1 other locations
- Kralovske Vinohrady University Hospital — Prague, Czechia (RECRUITING)
- František Duška — Praha, Česká Republika, Czechia (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diarrhea Caused by Drug, Clostridium Difficile Infections, gut microbiota, critically ill, fecal microbial transplantation