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Recruiting Phase 3

Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

NCT05035342 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2024-01-11
Last updated
2025-05-25

Condition(s) studied

Enterobacteriaceae InfectionsFecal Microbiota Transplantation

Investigational drug(s) / intervention(s)

Fecal Microbiota Transplantation (FMT) capsules →Placebo capsules

Fecal Microbiota Transplantation (FMT) capsules: Donated fecal matter will be sequentially diluted in 80% glycerol used as bacterial cryoprotectant, blenderized, sieved and centrifuged (4°C, 4000 tr/min, 20 min). The pellet is resuspended and manually pipetted into size 0 capsules (650 μL), which are closed and then secondarily sealed in size 00 capsules (hypromellose capsules, DR caps from Capsugel®, MA). Each capsule contains 1g ± 0,1g of fecal suspension corresponding to 0.5 to 0.8g of native stool. Capsules will be stored frozen at -80°C for up to 24 months pending use. The stability of biodiversity and viability of the frozen microbiota was regularly verified to ensure the efficacy of the transplantation (personal data).

Placebo capsules: The "placebo" FMT capsules will be performed with the final dilution solution, ie the 80% glycerol solution used as a cryoprotectant. This solution will be double encapsulated like the FMT capsules.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
105 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Determine whether FMT with frozen capsules is effective for decolonization of MDR-GNB. — 30 days post-randomization
    Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 30 (±10 days) after randomization as determined by culture methods

Trial sites (11)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05035342 on ClinicalTrials.gov ↗ ← All trials in France