Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease (SFMT-IBD)

• ClinicalTrials.gov Identifier: NCT02335281
• Recruitment Status: Unknown
• First Posted: January 9, 2015
• Last Update Posted: January 9, 2015
• Sponsor: Yanling Wei
• Information provided by (Responsible Party): Yanling Wei, Third Military Medical University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease	Procedure: FMT; Drug: Mesalazine	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease
• Study Start Date: January 2015
• Estimated Primary Completion Date: October 2017
• Estimated Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Standardized FMT; 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; Standardized FMT once
Active Comparator: Mesalazine; This group include 20 patients . The patients will receive traditional medicine of mesalazine treatment.	Drug: Mesalazine; 2g Po perday; Other Name: Mesalamine

Outcome Measures

Primary Outcome Measures :

1. Clinical remission (defined as HBI score ≦ 4) [ Time Frame: up to one year ]
   Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence

Secondary Outcome Measures :

1. Hospitalization days [ Time Frame: up to one year ]
   Hospitalization days from administration to discharge when at clinical remission.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Dongfeng Chen, doctor; 86-13883032812; chedf1981@126.com

Contact: Yanling Wei, doctor; 86-15310354666; lingzi016@126.com

Locations

China, Chongqing

Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University; Recruiting

Chongqing, Chongqing, China, 400042

Contact: Dongfeng Chen, doctor 86-13883032812 chendf1981@126.com

Contact: Yanling Wei, doctor 86-15310354666 lingzi016@126.com

Sponsors and Collaborators

Yanling Wei

Investigators

• Study Director: Dongfeng Chen, doctor; Third Military Medical University

More Information

• Responsible Party: Yanling Wei, Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University, Third Military Medical University
• ClinicalTrials.gov Identifier: NCT02335281
• Other Study ID Numbers: TMMU-DP-GI-FMT-001
• First Posted: January 9, 2015
• Last Update Posted: January 9, 2015
• Last Verified: January 2015

Keywords provided by Yanling Wei, Third Military Medical University:

Standardized Fecal Microbiota Transplantation; Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Additional relevant MeSH terms:

Inflammatory Bowel Diseases; Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Pathologic Processes; Mesalamine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents