Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01790061
Study type	Interventional
Source	The Second Hospital of Nanjing Medical University
Contact	Faming Zhang, MD,PhD
Phone	086-25-58509883
Email	fzhang@njmu.edu.cn
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	February 2013
Completion date	December 2025

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