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

Medical College of Wisconsin

Status: Withdrawn

Conditions: Clostridium Difficile Infection

Treatments: Other: Fecal microbiota

Study type: Interventional

Funder types: Other

Identifiers

NCT01842347

FMT

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Pediatrics, C. Diff.

Experimental group

Description:

Fecal Microbiota Transplantation in children with c. difficile infection

Treatment:

Other: Fecal microbiota