NCT01842347

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

3 years

First QC Date

April 25, 2013

Last Update Submit

December 12, 2013

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

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

    3 years

Study Arms (1)

Pediatrics, C. Diff.

EXPERIMENTAL

Fecal Microbiota Transplantation in children with c. difficile infection

Other: Fecal microbiota

Interventions

Fecal microbiotaOTHER
Pediatrics, C. Diff.

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 months of age
  • FMT procedure has been decided by the treating gastroenterologist and was based on:
  • 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
  • Moderate CDI not responding to vancomycin for at least a week.
  • Severe CDI with no response to vancomycin after 4 hours.
  • English speaking

You may not qualify if:

  • Lack of informed consent/assent.
  • Not eligible for FMT procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Steven Werlin, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor, Principal Investigator

Study Record Dates

First Submitted

April 25, 2013

First Posted

April 29, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2016

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations

US(1)