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

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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease
• Intervention / Treatment: Procedure: FMT; Drug: Mesalazine

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Mesalamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization days	Hospitalization days from administration to discharge when at clinical remission.	up to one year

Collaborators and Investigators

• Sponsor: Yanling Wei
• Investigators: Study Director: Dongfeng Chen, doctor, Third Military Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 9, 2015

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Crohn's Disease; Standardized Fecal Microbiota Transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: TMMU-DP-GI-FMT-001