Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients

ClinicalTrials.gov ID

NCT05430269

Lead Sponsor

Charles University, Czech RepublicOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

36Estimated

Last Update Posted

Feb 10, 2023Actual

Start Date

Feb 9, 2023Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Jul 1, 2025Estimated

Official Title

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

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 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.

• Diarrhea Caused by Drug
• Clostridium Difficile Infections

• Faecal bacteriotherapy (FBT)
• standard-of-care protocolised treatment of postantibiotic diarhea

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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).

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Charles University, Czech RepublicOTHER

Collaborators

Faculty Hospital Kralovske VinohradyOTHER_GOV

Donatio Intensivistam Endowment FundUNKNOWN

fduska@yahoo.com608405541

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