Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Phase 1

Completed

• Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; CD
• Interventions: Biological: Bacteriotherapy

• Registration Number: NCT01757964
• Lead Sponsor: David Suskind

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-22
• Study First Submitted QC: 2012-12-28
• Study First Posted: 2012-12-31
• Primary Completion: 2013-10
• Study Completion: 2015-01
• Results First Submitted: 2015-11-16
• Results First Submitted QC: 2016-04-18
• Results First Posted: 2016-05-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bacteriotherapy	Bacteriotherapy	Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States