Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis

Who is this study for? Patients with moderate to severe ulcerative colitis
What treatments are being studied? Standardized FMT
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies.

Locations
Other Locations
China
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Faming Zhang, MD,PhD
fzhang@njmu.edu.cn
086-25-58509883
Backup
Faming Zhang, MD,PhD
Time Frame
Start Date: 2013-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 500
Treatments
Experimental: Standardized FMT
endoscopy Tubing Once or repeat
Experimental: Traditional treatments
Oral Tubing
Authors
Sponsors
Collaborators: Air Force Military Medical University, China
Leads: The Second Hospital of Nanjing Medical University

This content was sourced from clinicaltrials.gov

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