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Bacteriotherapy in Pediatric Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01757964
Recruitment Status : Completed
First Posted : December 31, 2012
Results First Posted : May 25, 2016
Last Update Posted : May 30, 2017
Seattle Children's Hospital
Information provided by (Responsible Party):
David Suskind, Seattle Children's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis CD Biological: Bacteriotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Study Start Date : December 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01757964

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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
David Suskind
Seattle Children's Hospital
Publications of Results:
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Responsible Party: David Suskind, Associate Professor of Pediatrics, Seattle Children's Hospital Identifier: NCT01757964    
Other Study ID Numbers: 14267
First Posted: December 31, 2012    Key Record Dates
Results First Posted: May 25, 2016
Last Update Posted: May 30, 2017
Last Verified: April 2017
Keywords provided by David Suskind, Seattle Children's Hospital:
Crohns Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes