Predictive Value of pCLE Findings in Pediatric IBD

N/ACompletedNCT02003859

Scientific Center of Children's Health RAMS24 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Inflammatory Bowel Disease

Eligibility

Sex: ALLMin age: 10 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * signed informed consent * patients with established IBD Exclusion Criteria: * Any kind of allergy * Bronchial asthma * Liver or kidney disease * Inability to sign informed consent

Locations (1)

The Scientific Center of Children's Health

Moscow, Russia

Outcomes

Primary Outcomes

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.

Time frame: follow up period was a median of 18 months (range 4 to 33)

Data from ClinicalTrials.gov

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