Predictive Value of pCLE Findings in Pediatric IBD
1 other identifier
observational
24
1 country
1
Brief Summary
Studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be predictive of disease relapse in adult IBD patients. The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 30, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 19, 2014
November 1, 2014
4 years
November 30, 2013
November 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary study end-point was moderate to severe flare requiring hospitalization after pCLE
The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.
follow up period was a median of 18 months (range 4 to 33)
Eligibility Criteria
Pediatric patients with IBD from all over Russia, treated from IBD in our Center
You may qualify if:
- signed informed consent
- patients with established IBD
You may not qualify if:
- Any kind of allergy
- Bronchial asthma
- Liver or kidney disease
- Inability to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scientific Center of Children's Health RAMSlead
- University of Albertacollaborator
- Harvard Medical School (HMS and HSDM)collaborator
Study Sites (1)
The Scientific Center of Children's Health
Moscow, 119991, Russia
Related Publications (1)
Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.
PMID: 26513619DERIVED
Biospecimen
Optical biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrey A Shavrov, M.D.
The Scientififc Center of Children's Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
November 30, 2013
First Posted
December 6, 2013
Study Start
November 1, 2010
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 19, 2014
Record last verified: 2014-11