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Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01842347
Recruitment Status : Withdrawn
First Posted : April 29, 2013
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Steve Werlin, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE April 25, 2013
First Posted Date  ICMJE April 29, 2013
Last Update Posted Date December 13, 2013
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT) [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2013)
Changes in microbiome following FMT for recurrent or resistant C difficile infection [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
Official Title  ICMJE Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
Brief Summary The purpose of this study is to treat children with severe, moderate, resistant or relapsing C. difficile infection and to determine the changes in the intestinal microbiome (all of the bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data will be collected throughout the FMT procedure to determine effectiveness and to help standardize this procedure. Stool samples will be collected to look at the different bacteria that are in the intestines before and after FMT.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE Other: Fecal microbiota
Study Arms  ICMJE Experimental: Pediatrics, C. Diff.
Fecal Microbiota Transplantation in children with c. difficile infection
Intervention: Other: Fecal microbiota
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 12, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2013)
25
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Recipient Inclusion Criteria

  1. Older than 18 months of age
  2. FMT procedure has been decided by the treating gastroenterologist and was based on:

    1. Recurrent or relapsing CDI and:

      • Failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. Fidaxomicin is not approved for <18years and insurance authorization may not be possible).
      • At least 2 episodes of CDI requiring hospitalization
    2. Moderate CDI not responding to vancomycin for at least a week.
    3. Severe CDI with no response to vancomycin after 4 hours.
  3. English speaking

Recipient Exclusion Criteria

  1. Lack of informed consent/assent.
  2. Not eligible for FMT procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01842347
Other Study ID Numbers  ICMJE FMT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steve Werlin, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Werlin, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date December 2013

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