NCT00979485

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

September 17, 2009

Last Update Submit

June 22, 2011

Conditions

Crohn's DiseaseUlcerative Colitis

Keywords

Pediatric IBDMicroparticles

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric GI clinic at Riley Hospital Pediatric well child clinic at Riley Hospital

You may qualify if:

  • Children with IBD based on endoscopic, histologic, radiologic, or laboratory data
  • Ages between 8 and 17 years old

You may not qualify if:

  • Anyone with a concurrent illness since infection can affect microparticle levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana Unversity, Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Steven ' Steiner, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

US(1)