Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases
Recruiting now · Not applicable
Conditions studied: Inflammatory Bowel Disease, Crohn's Disease (CD)
In brief
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
Key facts
- Study ID
- NCT01793831
- Run by
- The Second Hospital of Nanjing Medical University
- People needed
- 800
- Starts
- 2013-02-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-11-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).
Where it is running
- The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University — Huai'an, Jiangsu, China (enrolling)
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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