Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01757964
• Other study ID #: 14267
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 22, 2012
• Last updated: December 11, 2013
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: December 2013
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 21 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CD
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Biological:
• Bacteriotherapy

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
David Suskind	Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Stool Transplantation	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.	12 weeks	Yes