RecruitingNot ApplicableNCT01793831

Standardized Fecal Microbiota Transplantation for Crohn's Diseases

Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn's Diseases

Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

800 participants

Start Date

Feb 1, 2013

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Disease Crohn's Disease (CD)

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

Inclusion Criteria2

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 Criteria1

Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).