Fecal Microbiota Transplantation for Ulcerative Colitis

Phase

2/3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT03804931

K-2017-103-01

Ages 18-65
All Genders

Study Summary

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Active, moderate to severe severity (Mayo score more than 6)
Safety using history of 5-ASA
Able to undergo endoscopy examination

Exclusion

Exclusion Criteria:

Antibiotic using in 7 days
High risk of toxic megacolon
Colon cancer or neoplasia in pathophysiology
Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidneydiseases)

Study Design

January 20, 2019

December 31, 2030

Study Description

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.

Connect with a study center

Guangzhou First People's Hospital
Guangzhou, Guangdong
China
Active - Recruiting

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