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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:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00979485
First received: September 17, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Steven Steiner, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00979485     History of Changes
Other Study ID Numbers: 0906-75
Study First Received: September 17, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Pediatric IBD
Microparticles

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

ClinicalTrials.gov processed this record on June 17, 2013