214
Participants
Start Date
January 11, 2024
Primary Completion Date
May 31, 2026
Study Completion Date
April 30, 2028
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."
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
Assistance Publique - Hôpitaux de Paris
OTHER