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Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

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ClinicalTrials.gov Identifier: NCT01793831
Recruitment Status : Recruiting
First Posted : February 18, 2013
Last Update Posted : January 9, 2018
Fourth Military Medical University
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Brief Summary:
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This is an initial step into investigating the potential efficacy of fecal bacteriotherapy for CD, the investigators propose to determine the efficiency, durability and safety of FMT in a series of 500 patients with CD in ten years.

Condition or disease Intervention/treatment Phase
Crohn's Diseases Inflammatory Bowel Disease Procedure: FMT Drug: 5-ASA, Prednisone, Azathioprine or Remicade Phase 2 Phase 3

Detailed Description:
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD (all age range,HBI>4). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to mid-gut (at least below the duodenal papilla) through regular gastroscope. Patients from multi-clinical centers in this study will be assigned to receive FMT only once or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, abdominal X-ray, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases
Study Start Date : November 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fecal microbiota transplantation
Standard fecal microbiota transplantation, once.
Procedure: FMT
Standard FMT, once
Sham Comparator: Traditional treatments, eg. 5-ASA
Traditional treatments according to associated guidelines, including 5-ASA, immunomodulatory therapy, corticoids, antibody
Drug: 5-ASA, Prednisone, Azathioprine or Remicade
Other Names:
  • Mesalamine
  • Corticoids
  • Immunomodulatory therapy
  • Infliximab

Primary Outcome Measures :
  1. Clinical remission [ 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. Costs [ Time Frame: Up to one year ]
    Social and medical costs

  2. Adverse events [ Time Frame: During FMT and ten years after FMT ]
    All possible adverse events:fever,abdominal pain,infectious diseases and others

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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Moderate to severe CD define as HBI score > 4.
  • Montreal classification: no limitation, except age> 6.

Exclusion Criteria:

  • Diagnosis as CD first time or first year.
  • No history of using 5-ASA, biological or immunomodulatory therapy

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): NCT01793831

Contact: Faming Zhang, MD,PhD 086-25-58509883 fzhang@njmu.edu.cn
Contact: Huijie Zhang, MD, PhD 086-25-58509670 zhjssm@163.com

China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883    fzhang@njmu.edu.cn   
Principal Investigator: Faming Zhang         
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fourth Military Medical University


Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01793831     History of Changes
Other Study ID Numbers: FMC-CN-121101
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
Crohn's diseases
Inflammatory bowel disease
Fecal transplantation
Fecal bacteriotherapy
Fecal microbiota transplantation

Additional relevant MeSH terms:
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents