Immune Responses to Gluten
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gluten Powder.
- Who it may be relevant to
- Registry conditions: Celiac Disease, Malabsorption Syndromes, Digestive System Disease, Intestinal Disease. Basic parameters: 2 years — 101 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
Overview
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Detailed 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.
Interventions
- Dietary supplement Gluten Powder
Single oral dose of gluten powder
Primary outcome measures
- Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten [Time frame: Baseline, 4 hours]
Eligibility criteria
Inclusion criteria
- On a gluten-free diet for ≥ 4 weeks
- Willing to consume gluten for research
- For the celiac disease arm, diagnosis confirmed by serology and/or histology
Exclusion criteria
- Pregnancy
- Wheat allergy
- Type 1 diabetes
- BMI z-score < -2
- History of more than minimal symptoms following gluten exposure on a gluten-free diet
- Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Children's Hospital Colorado — Aurora
- Boston Children's Hospital — Boston
Publications
- 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. PMID 31457091
- 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. PMID 31505020
- 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. PMID 31483515
Identifiers
NCT: NCT05209568 · P00039708