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This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluten challenge | Gluten containing or gluten-free study food in established celiac disease patients | ||
| Observation | Observation in newly diagnosed celiac disease patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms using patient reported outcome instruments | Sensitivity of the patient reported outcome instruments to detect change over time in celiac disease symptoms with and without a gluten challenge | 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - incidence of adverse events | Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events | 8 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Biopsy proven celiac disease patients
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Adelman, MD | Alvine Pharmaceuticals Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States | ||
| Kaiser Permanente Southern California, Allergy Department |
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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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| San Diego |
| California |
| 92111 |
| United States |
| University of Colorado, Denver | Aurora | Colorado | 80045 | United States |
| University of Chicago Celiac Disease Center | Chicago | Illinois | 60637 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2X8 | Canada |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |