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Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
Sponsor: The Second Hospital of Nanjing Medical University
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 FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).
Official title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
Key Details
Gender
All
Age Range
6 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2013-02
Completion Date
2025-12
Last Updated
2024-04-19
Healthy Volunteers
No
Conditions
Interventions
Standardized FMT
Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon
Traditional treatments
Medications
Locations (1)
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China