Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT05430269
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05430269
Study Brief:
Protocol Section:
NCT05430269