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NCT00979485 Clinical Trial

Microparticles in Pediatric Inflammatory Disease

Ulcerative Colitis Clinical Trial

Official title:
Microparticles in Pediatric Inflammatory Bowel Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00979485
Other study ID # 0906-75
Secondary ID
Status Terminated
Phase N/A
First received September 17, 2009
Last updated June 22, 2011
Start date August 2009
Est. completion date May 2011

Study information
Verified date June 2011
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 17 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Indiana Unversity, Riley Hospital for Children Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

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