Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients

NCT05430269 | Unknown

• 1 other identifier: 2021-002290-25
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Diarrhea Caused by Drug; Clostridium Difficile Infections

Keywords

gut microbiota; critically ill; fecal microbial transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison of therapeutic efficacy

  7 days after randomisation

• Systemic inflammation

  7 days after randomisation

• Organ failures

  7 days after randomisation

• Postprocedural bacteriaemia

  3 hours after intervention

• Mortality

  28 day or hospital discharge, whichever occurs earlier

Study Arms (2)

Intervention group

EXPERIMENTAL

ICU patients who developed diarhea after a course of antibiotic therapy treated with Faecal bacteriotherapy (FBT) delivered as enema

Other: Faecal bacteriotherapy (FBT)

Control group

ACTIVE COMPARATOR

ICU patients who developed diarhea after a course of antibiotic therapy treated standard-of-care protocolised treatment of postantibiotic diarhea

Other: standard-of-care protocolised treatment of postantibiotic diarhea

Interventions

Faecal bacteriotherapy (FBT) OTHER

Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.

Intervention group

standard-of-care protocolised treatment of postantibiotic diarhea OTHER

standard-of-care protocolised treatment of postantibiotic diarhea

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Faculty Hospital Kralovske Vinohrady: collaborator
• Donatio Intensivistam Endowment Fund: collaborator

Study Sites (2)

Kralovske Vinohrady University Hospital

Prague, 10034, Czechia

RECRUITING

František Duška

Prague, Česká Republika, 10034, Czechia

RECRUITING

Related Publications (1)

• Cibulkova I, Rehorova V, Soukupova H, Waldauf P, Cahova M, Manak J, Matejovic M, Duska F. Allogenic faecal microbiota transplantation for antibiotic-associated diarrhoea in critically ill patients (FEBATRICE)-Study protocol for a multi-centre randomised controlled trial (phase II). PLoS One. 2024 Dec 27;19(12):e0310180. doi: 10.1371/journal.pone.0310180. eCollection 2024.

  PMID: 39729440 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Critical Illness

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: František Duška, MD, PhD, A/Prof, AFICM, EDIC

Model Details: Prospective, single center, parallel group randomised controlled trial.

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: June 24, 2022
• Study Start: February 9, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

CZ (2)