Microparticles in Pediatric Inflammatory Disease

Terminated

• Conditions: Crohn's Disease; Ulcerative Colitis

• Registration Number: NCT00979485
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to provide data correlating levels of microparticles that circulate in the blood and disease activity in children with inflammatory bowel disease (IBD). The hypothesis is that circulating microparticles will be higher in children with active IBD, show inflammatory activity, and will be low in patients in remission as well as in healthy controls.

Detailed Description

Once the response of microparticles to inflammation is defined in this patient population, the microparticles can be used as biomarkers of disease activity and could potentially use microparticles as targets of therapeutic agents.

This cross sectional study will enroll 15 Crohn's patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric Crohn's disease activity index), 15 Ulcerative Colitis patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric ulcerative colitis activity index), and 10 healthy controls.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children with IBD based on endoscopic, histologic, radiologic, or laboratory data
• Ages between 8 and 17 years old

Exclusion Criteria

• Anyone with a concurrent illness since infection can affect microparticle levels

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Indiana Unversity, Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States