Status:

UNKNOWN

Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients

Lead Sponsor:

Schneider Children's Medical Center, Israel

Conditions:

Celiac Disease in Children

Eligibility:

All Genders

Up to 17 years

Brief Summary

A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology tes...

Detailed Description

I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. In this s...

Eligibility Criteria

Inclusion

  • Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.

Exclusion

  • Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
  • Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
  • NSAID use in the last week.
  • Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
  • Known genetic disorders (such as Down's syndrome).
  • Patients whose TTG was elevated but lower than 3 times the normal range.

Key Trial Info

Start Date :

November 1 2017

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2020

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT03244254

Start Date

November 1 2017

End Date

August 1 2020

Last Update

October 4 2017

Active Locations (1)

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Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients | DecenTrialz