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OpenTrials
Completed

NCT Number: NCT02003859

Predictive Value of pCLE Findings in Pediatric IBD

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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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Scientific Center of Children's Health

Moscow, 119991, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary study end-point was moderate to severe flare requiring hospitalization after pCLE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Scientific Center of Children's Health RAMS

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • University of Alberta

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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