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| Name | Class |
|---|---|
| ImmusanT, Inc. | INDUSTRY |
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The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.
Participants meeting eligibility criteria will have blood collected before and after a three-day oral gluten challenge. This blood will be tested for biomarkers associated with islet autoimmunity and gluten-specific cellular immunity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celiac Disease Alone Gluten Challenge | Experimental |
| |
| Celiac Disease Alone Sham Challenge | Sham Comparator |
| |
| Celiac Disease and T1D Gluten Challenge | Experimental |
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| Celiac Disease and T1D Sham Challenge | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten Challenge | Dietary Supplement | Three-day gluten containing dietary challenge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Markers of Autoimmunity | Blood samples for markers of autoimmunity will be taken before and day 3 post challenge. | Baseline and day 3 post challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptoms | Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge. | Baseline and 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Gaglia, MD, MMSc | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Sham Challenge | Dietary Supplement | Three-day sham (gluten free) dietary challenge |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |