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Recruiting NCT01793831

Standardized Fecal Microbiota Transplantation for Crohn's Diseases

Trial Parameters

Condition Inflammatory Bowel Disease
Sponsor The Second Hospital of Nanjing Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 800
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2013-02
Completion 2025-12
Interventions
FMT

Brief 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

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up. Willingness to undergo FMT (Fecal Microbiota Transplantation). Exclusion Criteria: Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).

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