Overview

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Status:
Recruiting

Trial end date:
2032-12-01

Target enrollment:
0

Participant gender:
All

Summary

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The Second Hospital of Nanjing Medical University

Collaborators:

Air Force Military Medical University, China
Fourth Military Medical University

Criteria

Inclusion Criteria:

Moderate to serious UC (Montreal classification)

Exclusion Criteria:

Diagnosed as UC first time. No history of using Biologic,immunomodulatory therapy or
corticosteroid therapy.

With contraindication of endoscopy.