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NCT02435160 Clinical Trial

The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02435160
Other study ID # 20150406
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received April 23, 2015
Last updated May 5, 2015
Start date May 2015

Study information
Verified date April 2015
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria:

- mild to moderate UC patients

- male

- volunteered to our FMT trial

Exclusion Criteria:

- severe UC

- Hb < 6g/dL

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Fecal Microbiota Transplantation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jun Liu

Outcome
Type Measure Description Time frame Safety issue
Primary Change of mayo criteria in UC patients after FMT. one year Yes
Primary Number of patients with adverse events after FMT. one year Yes
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