Immune Responses to Gluten

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05209568

Enrollment

400

Registered

2022-01-26

Start date

2023-01-15

Completion date

2029-09-30

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease, Celiac Disease in Children, Digestive System Disease, Gastrointestinal Diseases, Gluten Sensitivity, Intestinal Disease, Malabsorption Syndromes

Keywords

gluten, cytokine, T cell immune response

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.

Interventions

DIETARY_SUPPLEMENTGluten Powder

Single oral dose of gluten powder

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

2 Years to 101 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten	Baseline, 4 hours	To determine the change in serum IL-2 level from baseline after a single oral dose of gluten

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJocelyn A Silvester, MD, PhD

McMaster University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026