Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-01-15
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Celiac Disease
Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology
Gluten Powder
Single oral dose of gluten powder
Healthy Controls
Individuals without a diagnosis of celiac disease
Gluten Powder
Single oral dose of gluten powder
Interventions
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Gluten Powder
Single oral dose of gluten powder
Eligibility Criteria
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Inclusion Criteria
2. Willing to consume gluten for research
3. For the celiac disease arm, diagnosis confirmed by serology and/or histology
Exclusion Criteria
2. Wheat allergy
3. Type 1 diabetes
4. BMI z-score \< -2
5. History of more than minimal symptoms following gluten exposure on a gluten-free diet
6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
2 Years
101 Years
ALL
Yes
Sponsors
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Children's Hospital Colorado
OTHER
Celiac Disease Foundation
UNKNOWN
Boston Children's Hospital
OTHER
Responsible Party
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Jocelyn Silvester
Director of Research, Celiac Disease Program
Principal Investigators
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Jocelyn A Silvester, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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P00039708
Identifier Type: -
Identifier Source: org_study_id
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