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Microparticles in Pediatric Inflammatory Disease

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ClinicalTrials.gov Identifier: NCT00979485
Recruitment Status : Terminated (initial results suggest no significant trends will be observed with completion of study)
First Posted : September 18, 2009
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Crohn's Disease Ulcerative Colitis

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 Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Microparticles in Pediatric Inflammatory Bowel Disease
Study Start Date : August 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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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
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979485


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

Responsible Party: Steven Steiner, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00979485     History of Changes
Other Study ID Numbers: 0906-75
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Indiana University:
Pediatric IBD
Microparticles

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases