Predictive Value of pCLE Findings in Pediatric IBD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02003859

Enrollment

Registered

2013-12-06

Start date

2010-11-30

Completion date

2014-11-30

Last updated

2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

IBD, Pediatrics, pCLE

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Russia

Outcome results