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RECRUITING
NCT01793831
NA

Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

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 fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period

Official title: Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2013-02

Completion Date

2025-12

Last Updated

2024-11-29

Healthy Volunteers

No

Interventions

PROCEDURE

FMT

Standard FMT

Locations (2)

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

Huai'an, Jiangsu, China

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

Nanjing, Jiangsu, China