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RECRUITING
NCT01790061
PHASE2/PHASE3

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Sponsor: The Second Hospital of Nanjing Medical University

View on ClinicalTrials.gov

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).

Official title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis

Key Details

Gender

All

Age Range

6 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2013-02

Completion Date

2025-12

Last Updated

2024-04-19

Healthy Volunteers

No

Interventions

PROCEDURE

Standardized FMT

Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon

DRUG

Traditional treatments

Medications

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China