Status:
UNKNOWN
Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients
Lead Sponsor:
Charles University, Czech Republic
Collaborating Sponsors:
Faculty Hospital Kralovske Vinohrady
Donatio Intensivistam Endowment Fund
Conditions:
Diarrhea Caused by Drug
Clostridium Difficile Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05430269
Start Date
February 9 2023
End Date
July 1 2025
Last Update
February 10 2023
Active Locations (2)
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1
Kralovske Vinohrady University Hospital
Prague, Czechia, 10034
2
František Duška
Prague, Česká Republika, Czechia, 10034