Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
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