Using fecal transplantation to eliminate drug-resistant bacteria

Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

This study is testing whether using fecal transplants can help adults get rid of harmful drug-resistant bacteria in their gut.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 18 Years to 105 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 11 sites (Clichy and 10 other locations)
• Trial ID: NCT05035342 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of fecal microbiota transplantation (FMT) as a method to decolonize patients carrying multi-drug resistant Gram-negative bacteria (MDR-GNB). The study aims to assess the efficacy of FMT capsules compared to placebo in eradicating these harmful bacteria from the gut microbiome. Given the rising threat of antibiotic resistance, this approach could provide a novel solution to prevent infections and reduce the spread of MDR-GNB in healthcare settings and communities. Participants will include adults with documented MDR-GNB colonization or infection, and healthy volunteers will provide fecal samples for transplantation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 105 who have tested positive for drug-resistant Enterobacteriaceae.

Not a fit: Patients currently receiving antibiotic treatment or those in intensive care may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of infections caused by drug-resistant bacteria, improving patient outcomes and public health.

How similar studies have performed: Previous studies have shown promising results for fecal microbiota transplantation in decolonizing drug-resistant bacteria, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria for patients:

* ≥ 18 years and \< 105 years
* Patient with at least one positive rectal swab for enterobacteria:

extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenem-resistant Enterobacteriaceae (CRE), or who have had an ESBL-E or CRE infection within the year For ESBL-E carriers: an ESBL-E infection within the year is mandatory

\- Patient able to take 50 capsules orally in a day and without swallowing disorders

Inclusion Criteria for healthy volunteers donors:

* Healthy subjects ≥ 18 years and \< 50 years
* Body mass index \< 30 kg/m\^2
* Regular bowel movement defined as at least 1 stool every 2 daysand maximum than 3 stools per day

Exclusion Criteria:

Exclusion Criteria for patients:

* Current antibiotic treatment with te exception of long term antibiotic prophylaxis (duration of at least 3 months/year)
* Patients hospitalized in the intensive care unit
* Pregnancy or breastfeeding during the study
* Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control \[such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)\] to avoid pregnancy for the entire study
* Patient under legal protection
* Participation in another interventional study
* Non-affiliation to a social security scheme
* Patient under AME
* Refusal to participate to the study

Exclusion Criteria for healthy volunteers donors:

* Any history of or current proctologic disease or any acute condition, which in the investigator's judgment could harm the volunteer and/or compromise or limit the evaluation of the protocol or data analysis (for details, please see protocol)
* Subject under legal protection
* Participation in any other interventional study
* No-affiliation to a social security scheme
* Subject under AME
* Refusal to participate to the study

Randomization criteria:

* Patient colonized with a carbapenem-resistant Enterobacteriaceae (CRE) and/or colonized with an extended spectrum β-lactamase producing Enterobacteriaceae (ESBL-E) at inclusion on stool culture
* Patient with an ESBL-E infection in the previous 12 months (only for participants no colonized with CRE).
* Compatible transplant (FMT) based on patient's serological profile (CMV/EBV) available

Where this trial is running

Clichy and 10 other locations

• Beaujon Hospital — Clichy, France (Not_yet_recruiting)
• Henri Mondor Hospital — Créteil, France (Not_yet_recruiting)
• Raymond Poincaré Hospital — Garche, France (Not_yet_recruiting)
• Bicêtre Hospital — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
• Bichat Hospital — Paris, France (Not_yet_recruiting)
• Bichat Hospital — Paris, France (Recruiting)
• La Pitié Salpêtrière Hospital — Paris, France (Not_yet_recruiting)
• Lariboisière Hospital — Paris, France (Not_yet_recruiting)
• Saint Antoine Hospital — Paris, France (Not_yet_recruiting)
• Saint Louis Hospital — Paris, France (Not_yet_recruiting)
• Tenon Hospital — Paris, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Victoire De Lastours, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Victoire De Lastours, MD, PhD

Conditions Enterobacteriaceae Infections; Fecal Microbiota Transplantation