Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

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.
 
ClinicalTrials.gov Identifier: NCT01790061
Recruitment Status : Recruiting
First Posted : February 13, 2013
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE February 9, 2013
First Posted Date  ICMJE February 13, 2013
Last Update Posted Date January 9, 2018
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2018)
Efficacy of FMT [ Time Frame: On year ]
The efficacy and durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2013)
durability of clinical remission [ Time Frame: One month ]
The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)
Change History Complete list of historical versions of study NCT01790061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2018)
Adverse events [ Time Frame: Ten years ]
Number and severity of adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2013)
  • Patients with worsened disease [ Time Frame: one year ]
    Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.
  • Adverse events [ Time Frame: one year ]
    Number of adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
Official Title  ICMJE Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
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, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).
Detailed Description The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bacteria
  • Microbiota
  • Fecal Microbiota Transplantation
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
Intervention  ICMJE
  • Procedure: Standardized FMT
    Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon
    Other Names:
    • Fecal Microbiota Transplantation
    • Fecal Microbiota Therapy
    • fecal transplantation
  • Drug: Traditional treatments
    Medications
    Other Name: Traditional treatments according to associated guidelines
Study Arms  ICMJE
  • Experimental: Standardized FMT
    endoscopy Tubing Once or repeat
    Intervention: Procedure: Standardized FMT
  • Experimental: Traditional treatments
    Oral Tubing
    Intervention: Drug: Traditional treatments
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2018)
500
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2013)
60
Estimated Study Completion Date  ICMJE December 2032
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Moderate to serious UC (Montreal classification)

Exclusion Criteria:

Diagnosed as UC first time. No history of using Biologic,immunomodulatory therapy or corticosteroid therapy.

With contraindication of endoscopy.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Faming Zhang, MD,PhD 086-25-58509883 fzhang@njmu.edu.cn
Contact: Faming Zhang, MD,PhD
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01790061
Other Study ID Numbers  ICMJE FMT-CN-121123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Faming Zhang, The Second Hospital of Nanjing Medical University
Study Sponsor  ICMJE The Second Hospital of Nanjing Medical University
Collaborators  ICMJE Fourth Military Medical University
Investigators  ICMJE
Study Chair: Huijie Zhang, MD,PhD The Second Afiliated Hospital of Nanjing Medical University
PRS Account The Second Hospital of Nanjing Medical University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP