Predictive Value of pCLE Findings in Pediatric IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Anton A. Shavrov

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrey A Shavrov, M.D.

Role: STUDY_CHAIR

The Scientififc Center of Children's Health

Locations

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The Scientific Center of Children's Health

Moscow, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED

PMID: 26513619 (View on PubMed)

Other Identifiers

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SCCH-001

Identifier Type: -

Identifier Source: org_study_id