Clinical Trial

Standardized Fecal Microbiota Transplantation for Crohn's Diseases

Recruiting
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Record status
This record was last updated November 29, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2013-02-14; most recent amendment 2024-11-26.
Trial Details
NCT Number NCT01793831
Lead Sponsor The Second Hospital of Nanjing Medical University
Collaborators: The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University, The First Affiliated Hospital of Air Force Medicial University
Conditions Inflammatory Bowel Disease, Crohn's Disease (CD)
Enrollment 800 participants
Start Date 2013-02
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-11-29