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

NCT ID: NCT01842347

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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

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Conditions

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Clostridium Difficile Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pediatrics, C. Diff.

Fecal Microbiota Transplantation in children with c. difficile infection

Group Type EXPERIMENTAL

Fecal microbiota

Intervention Type OTHER

Interventions

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Fecal microbiota

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

1. Lack of informed consent/assent.
2. Not eligible for FMT procedure
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Steve Werlin

MD, Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Werlin, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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FMT

Identifier Type: -

Identifier Source: org_study_id