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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979485
First Posted: September 18, 2009
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Indiana University
  Purpose
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
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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
Information from the National Library of Medicine

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
  More Information

Responsible Party: Steven Steiner, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00979485     History of Changes
Other Study ID Numbers: 0906-75
First Submitted: September 17, 2009
First Posted: September 18, 2009
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