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| Name | Class |
|---|---|
| Children's Hospital Colorado | OTHER |
| Celiac Disease Foundation | UNKNOWN |
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This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
This is a multi-site open-label single dose gluten challenge study. Participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celiac Disease | Experimental | Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology |
|
| Healthy Controls | Experimental | Individuals without a diagnosis of celiac disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten Powder | Dietary Supplement | Single oral dose of gluten powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten | To determine the change in serum IL-2 level from baseline after a single oral dose of gluten | Baseline, 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jocelyn A Silvester, MD, PhD | Contact | 617-355-8880 | jocelyn.silvester@childrens.harvard.edu | |
| Marisa Stahl, MD, MSCS | Contact | marisa.stahl@childrenscolorado.org |
| Name | Affiliation | Role |
|---|---|---|
| Jocelyn A Silvester, MD, PhD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31457091 | Background | Goel G, Tye-Din JA, Qiao SW, Russell AK, Mayassi T, Ciszewski C, Sarna VK, Wang S, Goldstein KE, Dzuris JL, Williams LJ, Xavier RJ, Lundin KEA, Jabri B, Sollid LM, Anderson RP. Cytokine release and gastrointestinal symptoms after gluten challenge in celiac disease. Sci Adv. 2019 Aug 7;5(8):eaaw7756. doi: 10.1126/sciadv.aaw7756. eCollection 2019 Aug. | |
| 31505020 |
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Individual participant demographic and cytokine data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D008286 | Malabsorption Syndromes |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This is a multi-center study of immune responses to gluten in persons with celiac disease and healthy controls. All participants will have baseline blood drawn to assess immune responses at baseline in addition to four hours after a single oral dose of gluten.
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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Goel G, Daveson AJM, Hooi CE, Tye-Din JA, Wang S, Szymczak E, Williams LJ, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Serum cytokines elevated during gluten-mediated cytokine release in coeliac disease. Clin Exp Immunol. 2020 Jan;199(1):68-78. doi: 10.1111/cei.13369. Epub 2019 Oct 1. |
| 31483515 | Background | Tye-Din JA, Daveson AJM, Ee HC, Goel G, MacDougall J, Acaster S, Goldstein KE, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Elevated serum interleukin-2 after gluten correlates with symptoms and is a potential diagnostic biomarker for coeliac disease. Aliment Pharmacol Ther. 2019 Oct;50(8):901-910. doi: 10.1111/apt.15477. Epub 2019 Sep 4. |