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

This study is currently recruiting participants.
Verified January 2015 by Yanling Wei, Third Military Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02335281
First Posted: January 9, 2015
Last Update Posted: January 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yanling Wei, Third Military Medical University
  Purpose
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 Intervention Phase
Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease Procedure: FMT Drug: Mesalazine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yanling Wei, Third Military Medical University:

Primary Outcome Measures:
  • 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:
  • Hospitalization days [ Time Frame: up to one year ]
    Hospitalization days from administration to discharge when at clinical remission.


Estimated Enrollment: 40
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335281


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     History of Changes
Other Study ID Numbers: TMMU-DP-GI-FMT-001
First Submitted: January 7, 2015
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:
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Pathologic Processes
Mesalamine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents


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