Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients

Clostridium Difficile Infections Clinical Trial

— FEBATRICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430269
• Other study ID #: 2021-002290-25
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Clostridium Difficile Infections
• Clostridium Infections
• Diarrhea
• Diarrhea Caused by Drug

Intervention

Other:
• Faecal bacteriotherapy (FBT)
Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.
• standard-of-care protocolised treatment of postantibiotic diarhea
standard-of-care protocolised treatment of postantibiotic diarhea

Locations

Country	Name	City	State
Czechia	Kralovske Vinohrady University Hospital	Prague
Czechia	František Duška	Praha	Ceská Republika

Sponsors (3)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Donatio Intensivistam Endowment Fund, Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	Difference of proportion of patients between intervention and control groups in whom the treatment failed. Failure is defined as treatment has either not been delivered or has not been effective to cure diarrhoea as per WHO definition	7 days after randomisation
Secondary	Comparison of therapeutic efficacy	Difference of proportion of patients between intervention and control groups who are diarhoea-free (WHO definition)	7 days after randomisation
Secondary	Systemic inflammation	Difference between intervention and control group in area under C-reactive protein plasma concentration curve	7 days after randomisation
Secondary	Organ failures	Difference between intervention and control group in SOFA score curve	7 days after randomisation
Secondary	Postprocedural bacteriaemia	Difference between intervention and control group in the percentage of positive blood cultures	3 hours after intervention
Secondary	Mortality	Difference between intervention and control group in the absolute risk of death (intention-to-treat analysis)	28 day or hospital discharge, whichever occurs earlier