Diarrhea Caused by DrugFEBATRICENCT05430269
Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients
A study testing Faecal bacteriotherapy (FBT) and standard-of-care protocolised treatment of postantibiotic diarhea in people with Diarrhea Caused by Drug and Clostridium Difficile Infections, run by Charles University, Czech Republic at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea Caused by Drug, Clostridium Difficile Infections
- What is being tested?
- Faecal bacteriotherapy (FBT) and standard-of-care protocolised treatment of postantibiotic diarhea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesCzechia
- Study dates
- 9 Feb 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Kralovske Vinohrady University Hospital
Prague, 10034
Frantisek Duska, +420267162451, frantisek.duska@fnkv.cz
- Recruiting
František Duška
Prague, Česká Republika, 10034
František Duška, 608405541, fduska@yahoo.com
About this study
Official title: Faecal Bacteriotherapy for Antibiotic-Associated Diarrhoea in Patients In Intensive Care - Randomised Controlled Trial
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.
Read more
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.
- Being tested
- Faecal bacteriotherapy (FBT), standard-of-care protocolised treatment of postantibiotic diarhea
- Keywords
- gut microbiota, critically ill, fecal microbial transplantation
- Medical subject headings
- Clostridium Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal bacteriotherapy (FBT)Other
Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.
standard-of-care protocolised treatment of postantibiotic diarheaOther
standard-of-care protocolised treatment of postantibiotic diarhea
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | ICU patients who developed diarhea after a course of antibiotic therapy treated with Faecal bacteriotherapy (FBT) delivered as enema Receives: 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 Receives: Other: standard-of-care protocolised treatment of postantibiotic diarhea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days after randomisation
Secondary outcomes (5)
Comparison of therapeutic efficacy
Difference of proportion of patients between intervention and control groups who are diarhoea-free (WHO definition)
Measured: 7 days after randomisation
Systemic inflammation
Difference between intervention and control group in area under C-reactive protein plasma concentration curve
Measured: 7 days after randomisation
Organ failures
Difference between intervention and control group in SOFA score curve
Measured: 7 days after randomisation
Postprocedural bacteriaemia
Difference between intervention and control group in the percentage of positive blood cultures
Measured: 3 hours after intervention
Mortality
Difference between intervention and control group in the absolute risk of death (intention-to-treat analysis)
Measured: 28 day or hospital discharge, whichever occurs earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start9 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea Caused by DrugStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single center, parallel group randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady, Donatio Intensivistam Endowment Fund
- Responsible party
- Principal investigator, Frantisek Duska, MD, PhD, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430269
- Sponsor's protocol ID
- 2021-002290-25
- Acronym
- FEBATRICE
- Status last verified
- Feb 2023
- First submitted
- 3 Apr 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39729440
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Bacteriotherapy for Antibiotic-Associated Diarrhoea in Patients In Intensive Care - Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05430269
- Acronym / sponsor ID
- FEBATRICE / 2021-002290-25
- Keywords
- gut microbiota, critically ill, fecal microbial transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady, Donatio Intensivistam Endowment Fund
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single center, parallel group randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Faecal bacteriotherapy (FBT)ICU patients who developed diarhea after a course of antibiotic therapy treated with Faecal bacteriotherapy (FBT) delivered as enema |
| Control group | Active comparator | Other: standard-of-care protocolised treatment of postantibiotic diarheaICU patients who developed diarhea after a course of antibiotic therapy treated standard-of-care protocolised treatment of postantibiotic diarhea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faecal bacteriotherapy (FBT)Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors. | Other | Intervention group |
| standard-of-care protocolised treatment of postantibiotic diarheastandard-of-care protocolised treatment of postantibiotic diarhea | Other | Control group |
Primary outcome
Treatment failure
Time frame: 7 days after randomisation
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
5 secondary outcomes
Comparison of therapeutic efficacy
Time frame: 7 days after randomisation
Systemic inflammation
Time frame: 7 days after randomisation
Organ failures
Time frame: 7 days after randomisation
Postprocedural bacteriaemia
Time frame: 3 hours after intervention
Mortality
Time frame: 28 day or hospital discharge, whichever occurs earlier
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 39729440Cibulkova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal bacteriotherapy (FBT) and standard-of-care protocolised treatment of postantibiotic diarhea in people with Diarrhea Caused by Drug and Clostridium Difficile Infections, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 7 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.