A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease

Who is this study for? Adult patients with Inflammatory Bowel Disease
What treatments are being studied? Fecal Microbiota Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

There are many limitations in the current treatments of Inflammatory bowel disease(IBD). Some patients have no or little reaction to the traditional drugs. Now the investigators realized that the intestinal microbiota is closely associated with the development of IBD. In recent years, a retrospective study showed that the overall efficiency of fecal microbiota transplantation (FMT) for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators plan to recruit patients with IBD (Ulcerative Colitis and Crohn's Disease) in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. The investigators aim to determine the efficiency, durability and safety of Fecal Microbiota Transplantation for IBD treatment, and further to explore which major microbiota may effect in this project.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Standard or conventional medicine treatment ineffective of IBD patients

• IBD patients with recurrent symptoms

• IBD patients who had drug dependence or recurrence when reduced or discontinued use

• Untreated IBD patients who voluntarily received FMT

Locations
Other Locations
China
Yanyun Fan
RECRUITING
Xiamen
Contact Information
Primary
Yanyun Fan, Doctor
trudy@163.com
18759212670
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 200
Treatments
Experimental: Standardized FMT
The patients will receive standardized FMT. The FMT was given by capsule. It was given three times a week.
Placebo_comparator: Without FMT
The patients will receive FMT with blank capsule.
Sponsors
Leads: Zhongshan Hospital Xiamen University

This content was sourced from clinicaltrials.gov

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