Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients
NCT ID: NCT05430269
Last Updated: 2023-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
36 participants
INTERVENTIONAL
2023-02-09
2025-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
NCT05578196
Fecal Microbiota Transplantation for Eradication of Carbapenem-resistant Enterobacteriaceae Colonization
NCT03391674
Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile Infection
NCT04960306
Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin
NCT01226992
Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract
NCT06001333
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
ICU patients who developed diarhea after a course of antibiotic therapy treated with Faecal bacteriotherapy (FBT) delivered as enema
Faecal bacteriotherapy (FBT)
Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.
Control group
ICU patients who developed diarhea after a course of antibiotic therapy treated standard-of-care protocolised treatment of postantibiotic diarhea
standard-of-care protocolised treatment of postantibiotic diarhea
standard-of-care protocolised treatment of postantibiotic diarhea
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Faculty Hospital Kralovske Vinohrady
OTHER_GOV
Donatio Intensivistam Endowment Fund
UNKNOWN
Charles University, Czech Republic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Frantisek Duska, MD, PhD
František Duška, MD, PhD, A/Prof, AFICM, EDIC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kralovske Vinohrady University Hospital
Prague, , Czechia
František Duška
Prague, Česká Republika, Czechia
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-002290-25
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.