Bacteriotherapy in Pediatric Inflammatory Bowel Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by (Responsible Party):
David Suskind, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01757964
First received: December 22, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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
CD
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757964

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

No publications provided

Responsible Party: David Suskind, Associate Professor of Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov 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
IBD

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014