Bacteriotherapy in Pediatric Inflammatory Bowel Disease

April 25, 2017 updated by: David Suskind
In this study, the investigators want to see if Bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis. Additionally, researchers want to learn whether this experimental therapy delays the need for starting additional medications to treat pediatric IBD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

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
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle 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

Ages Eligible for Study

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children ages 12-21 years old with a diagnosis of mild to moderate Ulcerative Colitis or Crohn's Disease
  • Willing parent to donate stool for the transplant

Exclusion Criteria:

  • Severe Disease
  • History of intra-abdominal abscess, intra-abdominal fistula or stricturing
  • History of other systemic diseases
  • The patient has received TNF inhibitors to treat their IBD within two months of transplant

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bacteriotherapy
Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.
Biological: Bacteriotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring
Time Frame: 2 weeks
The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.
2 weeks

Collaborators and Investigators

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

Sponsor

David Suskind

Collaborators

Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 22, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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