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Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by The Second Hospital of Nanjing Medical University
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01793831
First received: February 13, 2013
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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 30 patients with CD (included cased according Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3 but without perianal diseases).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Crohn&Apos;s Diseases in Ileum and Colon

Resource links provided by NLM:


Further study details as provided by The Second Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • Clinical remission [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Hospitalization days from administration to discharge when at clinical remission.

  • Adverse events: fever and worsen abdominal pain. [ Time Frame: Up to three days ] [ Designated as safety issue: Yes ]
    Adverse events: fever and worsen abdominal pain within three days after FMT.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD. We established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria 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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe CD define as HBI score ≥ 9.
  • Moderate CD 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 CD first time or first year.
  • No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793831

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

Locations
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         
China, Shaanxi
Xijing Hospital of Digestive diseases Recruiting
Xi&apos;an, Shaanxi, China, 710032
Contact: Mi Tian       xjyyxh@fmmu.edu.cn   
Principal Investigator: Kaichun Wu         
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fourth Military Medical University
  More Information

Additional Information:
Publications:
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
Study First Received: February 13, 2013
Last Updated: November 21, 2014
Health Authority: China: Ministry of Health

Keywords provided by The Second Hospital of Nanjing Medical University:
Crohn&apos;s diseases
Inflammatory bowel disease
Fecal transplantation
Fecal bacteriotherapy
Fecal microbiota transplantation

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Azathioprine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014