Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients
Study Details
Study Description
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 testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- I-FABP levels at diagnosis [1 day of enrollment]
Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.
- I-FABP levels during remission [6 months & 12 months after enrollment]
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)
Eligibility Criteria
Criteria
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:
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Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
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Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
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NSAID use in the last week.
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Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
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Known genetic disorders (such as Down's syndrome).
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Patients whose TTG was elevated but lower than 3 times the normal range.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Schneider Children's Medical Center of Israel | Petaẖ Tiqwa | Israel |
Sponsors and Collaborators
- Schneider Children's Medical Center, Israel
Investigators
- Study Director: Raanan Shamir, Prof, Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SchneiderCMCIsraelIFABP