Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

August 30, 2016 updated by: Sonia Michail, MD, MemorialCare Health System

A Randomized, Placebo-controlled Pilot Trial to Administer Fecal Microbial Therapy (Stool Transplant) or Placebo in Children Ages 8 to 18 With Recurrent C. Difficile Infection

The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. The annual US financial burden associated with this infection is great and estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial ecology is disrupted during interventions notorious for perturbing the delicate microbial balance. A well known and common example is the use of antibiotics. Fecal microbiota transplant (FMT) has been introduced several decades ago in an attempt to restore the gut microbial balance. To this date there have been a great number of reports of success in eliminating recurrent C. difficile infections and restoring the gut microbial profile to resemble that of the healthy donor. While over 300 cases have been described in the literature, there has been no pediatric controlled studies performed to compare its efficacy to placebo. Therefore, there is a strong need to determine their safety and efficacy in pediatric randomized controlled studies. The investigators hypothesize that children with recurrent C. difficile infection will respond to fecal transplant therapy which will modify their gut microbial profile. The investigators propose a randomized, placebo controlled, pilot study of fecal microbial transplant in children with recurrent C. difficile infection to evaluate the safety and efficacy of fecal microbial transplant in children in preventing recurrent C. difficile infection. The investigators anticipate that fecal microbial transplant in children with recurrent C. difficile infection will be safe and efficacious and will provide these children with a great alternative to a disease that is difficult to treat. Results of this study will establish the major role of the gut microbiome in this disease and demonstrate the viability of gut microbial transplant in recipients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Forty six children with recurrent C. difficle infection will be randomized 1:1 to receive either fecal microbial transplant or placebo. The safety and efficacy of this intervention will be monitored for one year.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90806
        • Miller Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 1-21.
  2. Recurrent C. difficile infection defined as the occurrence of more than two infections

Exclusion Criteria:

  1. Inflammatory bowel disease
  2. Immune-deficiency.
  3. Allergy to oral vancomycin.
  4. Children colonized with Clostridium difficile without evidence of symptoms to suggest colitis such as diarrhea and/or rectal bleeding.
  5. Concurrent infections that require anti-microbial therapy.
  6. Unable to give informed consent/assent.
  7. Pregnancy.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: FMT or fecal microbial transplant
intervention is fecal microbial transplant done through endoscopy, subjects will be randomized 1:1 to receive either FMT or placebo
Biological: FMT
as explained in study arm
Other Names:
  • stool transplant
  • fecal microbial transplant
PLACEBO_COMPARATOR: placebo
1:1 randomization to FMT versus placebo (which is saline or salt water)
Biological: placebo
salt water or saline will be given as placebo
Other Names:
  • saline
  • salt water

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary efficacy outcome of this randomized, controlled, double-blinded study is the time of recurrence of an infection
Time Frame: 12 months
secondary outcome measures are focused on the safety of Fecal microbial transplant in this population and all subjects will be closely monitored for developing adverse events for 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
safety of fecal microbial transplant in children with recurrent clostridium difficile
Time Frame: 12 months
All subjects will be closely monitored for adverse events for 12 months after fecal transplant. Subjects will be asked to report any adverse events as they occur and will also be monitored during each visits especially fever, bloating, abdominal pain, vomiting, diarrhea, and rectal bleeding.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MemorialCare Health System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Memorial Medical Center Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sonia Michail, MD, MemorialCare Health Servies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 093-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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