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CompletedNCT02003859Updated Nov 19, 2014

Predictive Value of pCLE Findings in Pediatric IBD

An observational study in Inflammatory Bowel Disease, sponsored by Scientific Center of Children's Health RAMS. Completed at 1 site in Russian Federation. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2014-11-19.

Sponsored by Scientific Center of Children's Health RAMS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
10 Years to 21 Years
Sex
All
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Study 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.

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Conditions studied

  • Inflammatory Bowel Disease

Keywords

  • IBD
  • Pediatrics
  • pCLE
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In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's enrollment of 24 is below the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

This is the only study on the registry with Scientific Center of Children's Health RAMS as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pediatric patients with IBD from all over Russia, treated from IBD in our Center

Inclusion criteria

  • signed informed consent
  • patients with established IBD

Exclusion criteria

Exclusion Criteria:

  • Any kind of allergy
  • Bronchial asthma
  • Liver or kidney disease
  • Inability to sign informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No
Biospecimen retention
None retained
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What researchers measure

Primary outcomes

  1. 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)

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Study locations

1 site
  • The Scientific Center of Children's Health
    Moscow, 119991, Russian Federation
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References and documents

Publications

  • 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. PubMed 26513619 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02003859
Lead sponsor
Scientific Center of Children's Health RAMS
Collaborators
University of Alberta, Harvard Medical School (HMS and HSDM)
Responsible party
Anton A. Shavrov (M.D., Scientific Center of Children's Health RAMS) — Principal investigator
First posted
Dec 6, 2013
Start date
Nov 2010
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Nov 19, 2014

Study contacts

Andrey A Shavrov, M.D.
study chair · The Scientififc Center of Children's Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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