Trial | NCT02335281  Report issue

Title

Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease
Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
In this projects the investigators aim to re-establish a gut balance of intestinal microecological through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We will establish a standardized isolation, store, and transportion steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized FMT only once or traditional medicine of mesalazine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, abdominal CT, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects.
Study Started
Jan 31
2015
Primary Completion
Oct 31
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Jan 09
2015
Estimate

Procedure FMT

Standardized FMT once

Drug Mesalazine

2g Po perday

  • Other names: Mesalamine

Standardized FMT Experimental

The group include 20 patients. They will receive standardized FMT. The FMT was given to mid-gut by nose-jejunum nutrition tube. It was given only once.

  • Procedure FMT

Mesalazine Active Comparator

This group include 20 patients . The patients will receive traditional medicine of mesalazine treatment.

Criteria 

Inclusion Criteria:

Severe IBD define as HBI score ≥ 9.
Moderate IBD define as 7<HBI <9
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
No Results Posted