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RECRUITING
NCT05035342
PHASE3

Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

BIOLOGICAL

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).

BIOLOGICAL

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