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NCT05209568 Clinical Trial

Immune Responses to Gluten

Celiac Disease Clinical Trial

Official title:
Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05209568
Other study ID # P00039708
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date September 30, 2029

Study information
Verified date January 2024
Source Boston Children's Hospital
Contact Jocelyn A Silvester, MD, PhD
Phone 617-355-8880
Email jocelyn.silvester@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date September 30, 2029
Est. primary completion date September 30, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 101 Years
Eligibility Inclusion Criteria: 1. On a gluten-free diet for = 4 weeks 2. Willing to consume gluten for research 3. For the celiac disease arm, diagnosis confirmed by serology and/or histology Exclusion Criteria: 1. Pregnancy 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Gluten Powder
Single oral dose of gluten powder

Locations
Country Name City State
United States Children's Hospital Colorado Aurora Colorado
United States Boston Children's Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Boston Children's Hospital Celiac Disease Foundation, Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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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