Crohn's DiseaseNCT00979485
Microparticles in Pediatric Inflammatory Disease
An observational study of Crohn's Disease and Ulcerative Colitis, run by Indiana University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric GI clinic at Riley Hospital Pediatric well child clinic at Riley Hospital
Who may be able to join
- Children with IBD based on endoscopic, histologic, radiologic, or laboratory data
- Ages between 8 and 17 years old
Who cannot join
- Anyone with a concurrent illness since infection can affect microparticle levels
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Unversity, Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: Microparticles in Pediatric Inflammatory Bowel Disease
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.
Read the 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Pediatric IBD, Microparticles
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: initial results suggest no significant trends will be observed with completion of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Steven ' Steiner, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979485
- Sponsor's protocol ID
- 0906-75
- Status last verified
- Jun 2011
- First submitted
- 17 Sep 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticles in Pediatric Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00979485
- Acronym / sponsor ID
- 0906-75
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Pediatric IBD, Microparticles
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: initial results suggest no significant trends will be observed with completion of study
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric GI clinic at Riley Hospital Pediatric well child clinic at Riley Hospital
Key inclusion criteria (2 listed)
- Children with IBD based on endoscopic, histologic, radiologic, or laboratory data
- Ages between 8 and 17 years old
Key exclusion criteria (1 listed)
- Anyone with a concurrent illness since infection can affect microparticle levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: initial results suggest no significant trends will be observed with completion of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven ' Steiner, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: initial results suggest no significant trends will be observed with completion of study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011; AzTrials last refreshed its copy on 29 Oct 2026.