Predictive Value of pCLE Findings in Pediatric IBD

Completed

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT02003859
• Lead Sponsor: Scientific Center of Children's Health RAMS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2013-11-30
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary study end-point was moderate to severe flare requiring hospitalization after pCLE	follow up period was a median of 18 months (range 4 to 33)	The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.

Trial Locations

Locations (1)

The Scientific Center of Children's Health; 🇷🇺 Moscow, Russian Federation