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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients undergoing endoscopy at the research hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Assaf Hoofien, Dr. | Contact | 972523310096 | Laerites@gmail.com | |
| Raanan Shamir, Prof. | Contact | RaananS@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Raanan Shamir, Prof | Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center of Israel | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |