Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Fecal microbiota

Other
Who is being recruted

Bacterial Infections and Mycoses+2

+ Bacterial Infections

+ Infections

Over 18 Months
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2013
See protocol details

Summary

Principal SponsorMedical College of Wisconsin
Last updated: December 13, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01842347
Principal SponsorMedical College of Wisconsin
Last updated: December 13, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsInfectionsGram-Positive Bacterial InfectionsClostridium Infections

Criteria

2 exclusion criteria prevent from participating
Lack of informed consent/assent
Not eligible for FMT procedure

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Fecal Microbiota Transplantation in children with c. difficile infection

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Children's Hospital of Wisconsin

Milwaukee, United StatesOpen Children's Hospital of Wisconsin in Google Maps
SuspendedOne Study Center