Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 7, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Hepatic EncephalopathyDysbiosis
Interventions
PROCEDURE

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.

DRUG

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).

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Agostino Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER