Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

PHASE3RecruitingINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

January 11, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

April 30, 2028

Conditions
Enterobacteriaceae InfectionsFecal Microbiota Transplantation
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."

Trial Locations (11)

Unknown

NOT_YET_RECRUITING

Beaujon Hospital, Clichy

NOT_YET_RECRUITING

Henri Mondor Hospital, Créteil

NOT_YET_RECRUITING

Raymond Poincaré Hospital, Garche

NOT_YET_RECRUITING

Bicêtre Hospital, Le Kremlin-Bicêtre

NOT_YET_RECRUITING

Bichat Hospital, Paris

RECRUITING

Bichat Hospital, Paris

NOT_YET_RECRUITING

La Pitié Salpêtrière Hospital, Paris

NOT_YET_RECRUITING

Lariboisière Hospital, Paris

NOT_YET_RECRUITING

Saint Antoine Hospital, Paris

NOT_YET_RECRUITING

Saint Louis Hospital, Paris

NOT_YET_RECRUITING

Tenon Hospital, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER