Using fecal transplantation to eliminate drug-resistant bacteria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Bichat Hospital
  Paris, France Recruiting
• 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

Study contacts

• Principal investigator: Victoire De Lastours, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Victoire De Lastours, MD, PhD
• Email: victoire.de-lastours@aphp.fr
• Phone: +33 1 40 87 52 27

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.