Predictive Value of pCLE Findings in Pediatric IBD

Inflammatory Bowel Disease Clinical Trial

Official title:

Predictive Value of pCLE Findings in Pediatric IBD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003859
• Other study ID #: SCCH-001
• Status: Completed
• Phase: N/A
• First received: November 30, 2013
• Last updated: November 18, 2014
• Start date: November 2010
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Scientific Center of Children's Health RAMS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 21 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Russian Federation	The Scientific Center of Children's Health	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Scientific Center of Children's Health RAMS	Harvard Medical School, University of Alberta

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes