Clinical Trials Directory

Trials / Unknown

UnknownNCT03244254

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

I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission

Status
Unknown
Phase
Study type
Observational
Enrollment
70 (estimated)
Sponsor
Schneider Children's Medical Center, Israel · Academic / Other
Sex
All
Age
17 Years
Healthy volunteers
Not accepted

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 testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.

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 study a pediatric population of celiac patients will be tested for I-FABP levels during initial endoscopic diagnosis and during one year of follow up. Their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. During the period of follow up, the test group will undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. The results will be analyzed in the hope of finding a way to use I-FABP as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's Marsh score at diagnosis.

Conditions

Timeline

Start date
2017-11-01
Primary completion
2019-08-01
Completion
2020-08-01
First posted
2017-08-09
Last updated
2017-10-04

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT03244254. Inclusion in this directory is not an endorsement.