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

Celiac Disease in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03244254
• Other study ID #: SchneiderCMCIsraelIFABP
• Status: Not yet recruiting
• Phase: N/A
• First received: August 6, 2017
• Last updated: October 3, 2017
• Start date: November 2017
• Est. completion date: August 2020

Study information

• Verified date: October 2017
• Source: Schneider Children's Medical Center, Israel
• Contact: Assaf Hoofien, Dr.
• Phone: 972523310096
• Email: Laerites[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Peta? Tiqwa

Sponsors (1)

Lead Sponsor	Collaborator
Schneider Children's Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	I-FABP levels at diagnosis	Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.	1 day of enrollment
Primary	I-FABP levels during remission	Follow-up of I-FABP levels in test groups during follow-up meetings, comparison with other celiac serology taken at follow-up and adherence to gluten free diet (measured using adherence questionnaires)	6 months & 12 months after enrollment