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Bacteriotherapy in Pediatric Inflammatory Bowel Disease

This study has been completed.
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: April 18, 2016
Last verified: April 2016
  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:
  • 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: 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. 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.


Enrollment: 13
Study Start Date: December 2012
Study Completion Date: January 2015
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   (Child, Adult)
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

Publications:
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
Results First Received: November 16, 2015
Last Updated: April 18, 2016
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 September 29, 2016