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NCT01842347 Clinical Trial

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

Clostridium Difficile Infection Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01842347
Other study ID # FMT
Secondary ID
Status Withdrawn
Phase N/A
First received April 25, 2013
Last updated December 12, 2013
Start date August 2013

Study information
Verified date December 2013
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Months and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Fecal microbiota

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT) 3 years Yes
See also
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