Bacteriotherapy in Pediatric Inflammatory Bowel Disease
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.
Inflammatory Bowel Disease
|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|
- 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.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.