Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— SFMT-IBD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02335281
• Other study ID #: TMMU-DP-GI-FMT-001
• Status: Recruiting
• Phase: Phase 2
• First received: January 7, 2015
• Last updated: January 8, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2015
• Source: Third Military Medical University
• Contact: Dongfeng Chen, doctor
• Phone: 86-13883032812
• Email: chedf1981[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Procedure:
• FMT
Standardized FMT once

Drug:
• Mesalazine
2g Po perday

Locations

Country	Name	City	State
China	Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Yanling Wei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission (defined as HBI score ? 4)	Clinical remission defined as HBI score ? 4. The endpoint of follow-up is the time of clinical recurrence	up to one year	No
Secondary	Hospitalization days	Hospitalization days from administration to discharge when at clinical remission.	up to one year	No