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Microparticles in Pediatric Inflammatory Disease

This study has been terminated.
(initial results suggest no significant trends will be observed with completion of study)
Information provided by:
Indiana University Identifier:
First received: September 17, 2009
Last updated: June 22, 2011
Last verified: June 2011
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.

Crohn's Disease Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Microparticles in Pediatric Inflammatory Bowel Disease

Resource links provided by NLM:

Further study details as provided by Indiana University:

Estimated Enrollment: 40
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric GI clinic at Riley Hospital Pediatric well child clinic at Riley Hospital

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00979485

United States, Indiana
Indiana Unversity, Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Principal Investigator: Steven ` Steiner, MD Indiana University
  More Information

Responsible Party: Steven Steiner, MD, Indiana University Identifier: NCT00979485     History of Changes
Other Study ID Numbers: 0906-75
Study First Received: September 17, 2009
Last Updated: June 22, 2011

Keywords provided by Indiana University:
Pediatric IBD

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases processed this record on August 18, 2017