60
Participants
Start Date
April 7, 2021
Primary Completion Date
June 30, 2025
Study Completion Date
June 30, 2025
Fecal microbiota transplantation delivery through colonoscopy
Patients will receive 4 L of macrogol and salts solution the afternoon before FMT and remain fasting the night before the scheduled treatment. During colonoscopy, about 350 mL of donor fecal preparation will be infused in the cecum.
Fecal microbiota transplantation delivery through oral capsules
Intestinal gastro-resistant capsules (capacity 0.91 mL, overall 10\^8-9 bacteria per capsule) will be filled with the fecal slurry. From each donation weighing 100 g, it is expected to obtain 150 cps, which will be promptly frozen and stored at -80°C. At each monthly visit, the patient will receive 60 capsules, to be stored at -20°C at home. Capsules will be administered orally at the dose of 1 cps twice a day from month 1 post-colonoscopy to patients in the FMT group 1 (colonoscopy plus capsules), and from day 1 to patients in the FMT group 2 (capsules only).
RECRUITING
Fondazione Policlinico Agostino Gemelli IRCCS, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER