Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)

PHASE2RecruitingINTERVENTIONAL
Enrollment

466

Participants

Timeline

Start Date

April 9, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Fecal Microbiota TransplantationColorectal AdenomaGastrointestinal Microbiome
Interventions
PROCEDURE

fecal microbiota transplantation

We will use fecal suspensions and capsules prepared from the feces of healthy donors for fecal microbiota transplantation. Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).

Trial Locations (5)

518000

RECRUITING

Shenzhen Hospital of Southern Medical University, Shenzhen

Unknown

WITHDRAWN

Nanfang Hospital, Southern Medical University, Guangzhou

NOT_YET_RECRUITING

Luohu District People's Hospital, Shenzhen

NOT_YET_RECRUITING

Shenzhen University General Hospital, Shenzhen

NOT_YET_RECRUITING

Shunde Hospital of Southern Medical University, Shunde

All Listed Sponsors
lead

Shenzhen Hospital of Southern Medical University

OTHER