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Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Key Details
Gender
All
Age Range
18 Years - 105 Years
Study Type
INTERVENTIONAL
Enrollment
214
Start Date
2024-01-11
Completion Date
2028-04
Last Updated
2025-05-25
Healthy Volunteers
No
Interventions
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.
Locations (11)
Beaujon Hospital
Clichy, France
Henri Mondor Hospital
Créteil, France
Raymond Poincaré Hospital
Garche, France
Bicêtre Hospital
Le Kremlin-Bicêtre, France
Bichat Hospital
Paris, 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
Tenon Hospital
Paris, France