Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
Status:
Recruiting
Trial end date:
2032-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
The Second Hospital of Nanjing Medical University
Collaborators:
Air Force Military Medical University, China Fourth Military Medical University