Actively Recruiting
Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-25
214
Participants Needed
11
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of fecal microbiota transplantation (FMT) capsules as a way to clear multi-drug resistant and extensively drug-resistant Gram-negative bacteria (MDR-GNB) from the gut. These bacteria are a serious global health threat because they increase the risk of infections and spread easily in healthcare and community settings. This phase III randomized controlled trial aims to see if FMT capsules can effectively decolonize patients carrying carbapenem-resistant or extended-spectrum beta-lactamase producing Enterobacteriaceae, which currently have limited treatment options. The study compares two groups: one receiving FMT capsules made from healthy donor stool processed and frozen into capsules, and the other receiving placebo capsules containing only the solution used in FMT preparation. Participants will take 50 capsules in one day. This capsule form helps reduce side effects and supports outpatient treatment. The trial will assess the effect of FMT capsules versus placebo on bacterial decolonization and infection prevention over time. Participants will be monitored through stool cultures taken at the start, 30 days, and 90 days after treatment to check for bacterial clearance. Secondary assessments will track infection rates, safety, and tolerability for up to two years. The study includes detailed monitoring of microbiological and clinical outcomes, with the primary measure being clearance of MDR-GNB at 30 days post-randomization. The total follow-up may extend to two years to evaluate long-term effects and safety.
CONDITIONS
Brief Title
Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 105 years
- Positive rectal swab for extended-spectrum beta-lactamase-producing or carbapenem-resistant Enterobacteriaceae, or prior ESBL-E infection within the last year
- Ability to swallow 50 capsules in one day without swallowing difficulties
- For donors: healthy adults aged 18 to less than 50 years
- Donor body mass index less than 30 kg/m2
- Donor has regular bowel movements (1 stool every 2 days to 3 stools per day)
You will not qualify if you...
- Current antibiotic treatment except for long-term antibiotic prophylaxis
- Hospitalization in intensive care unit
- Pregnancy or breastfeeding
- Women of childbearing potential not using acceptable birth control methods
- Under legal protection
- Participation in another interventional study
- No social security affiliation or under AME
- Refusal to participate
- For donors: history of or current proctologic disease or acute conditions affecting safety or data
- Donor under legal protection
- Donor participation in other interventional studies
- Donor without social security affiliation or under AME
- Donor refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either fecal microbiota transplantation (FMT) capsules or placebo capsules in a single day to attempt decolonization of multidrug-resistant bacteria.
1 treatment visit (in-person)
Duration - Up to 2 years post-randomization
Participants are monitored for safety, tolerability, and prevention of infections following treatment.
Visits at baseline, 30 days, 90 days, and additional assessments up to 2 years
Trial Site Locations
Total: 11 locations
1
Beaujon Hospital
Clichy, France
Not Yet Recruiting
2
Henri Mondor Hospital
Créteil, France
Not Yet Recruiting
3
Raymond Poincaré Hospital
Garche, France
Not Yet Recruiting
4
Bicêtre Hospital
Le Kremlin-Bicêtre, France
Not Yet Recruiting
5
Bichat Hospital
Paris, France
Not Yet Recruiting
6
Bichat Hospital
Paris, France
Actively Recruiting
7
La Pitié Salpêtrière Hospital
Paris, France
Not Yet Recruiting
8
Lariboisière Hospital
Paris, France
Not Yet Recruiting
9
Saint Antoine Hospital
Paris, France
Not Yet Recruiting
10
Saint Louis Hospital
Paris, France
Not Yet Recruiting
11
Tenon Hospital
Paris, France
Not Yet Recruiting
Research Team
V
Victoire De Lastours, MD, PhD
H
Harry Sokol, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here