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

NCT ID: NCT03244254

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2020-08-31

Brief Summary

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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

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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

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Celiac Disease in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Test Group

Children up to 17 years of age at recruitment undergoing endoscopy in order to diagnose or rule out Celiac disease, whose Marsh score at endoscopy is 2 or higher.

No interventions assigned to this group

Control Group

Children up to 17 years of age undergoing endoscopy as part of abdominal pain workup, whose Celiac serology is negative, and the Marsh score found at endoscopy is 0.

No interventions assigned to this group

Eligibility Criteria

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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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schneider Children's Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Dr. Assaf Hoofien

Research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raanan Shamir, Prof

Role: STUDY_DIRECTOR

Director

Locations

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Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Assaf Hoofien, Dr.

Role: CONTACT

[email protected]
972523310096

Raanan Shamir, Prof.

Role: CONTACT

[email protected]

Facility Contacts

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Assafh Hoofien, Dr.

Role: primary

[email protected]
9720523310096

Other Identifiers

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SchneiderCMCIsraelIFABP

Identifier Type: -

Identifier Source: org_study_id