Bacteriotherapy in Pediatric Inflammatory Bowel Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by Seattle Children's Hospital.
Recruitment status was  Active, not recruiting
Seattle Children's Hospital
Information provided by (Responsible Party):
David Suskind, Seattle Children's Hospital Identifier:
First received: December 22, 2012
Last updated: December 11, 2013
Last verified: December 2013
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.

Condition Intervention Phase
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Biological: Bacteriotherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Resource links provided by NLM:

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Response to Stool Transplantation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01757964

United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
David Suskind
Seattle Children's Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Suskind, Associate Professor of Pediatrics, Seattle Children's Hospital Identifier: NCT01757964     History of Changes
Other Study ID Numbers: 14267 
Study First Received: December 22, 2012
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Children's Hospital:
Crohns Disease
Ulcerative Colitis
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases processed this record on May 23, 2016