Overview

Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development 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 will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yanling Wei
Treatments:
Mesalamine
Criteria
Inclusion Criteria:

- Severe IBD define as HBI score ≥ 9.

- Moderate IBD define as 7
- Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3.

Exclusion Criteria:

- Diarrhea activity scores < 3

- Severely active disease with perianal diseases

- Severely active disease with indication of surgery.

- Diagnosis as IBD first time or first year.

- No history of using 5-ASA, biological (antibody), immunomodulatory therapy,
corticosteroid therapy