Clinical trial NCT05209568: Immune Responses to Gluten
Official title: Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Celiac Disease
Malabsorption Syndromes
Digestive System Disease
Intestinal Disease
Gastrointestinal Diseases
Gluten Sensitivity
Celiac Disease in Children
Keywords: gluten
cytokine
T cell immune response
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
name: Celiac Disease Foundation
First posted: 2022-01-26
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 101
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
timeFrame: Baseline, 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jocelyn A Silvester, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.