Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Enterobacteriaceae Infections, Fecal Microbiota Transplantation

In brief

Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.

Key facts

Study ID: NCT05035342
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 214
Starts: 2024-01-11
Expected to finish: 2028-04-01
Last updated by the study team: 2025-05-25

Who can join

Age: 18 and older, up to 105. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

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