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Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?

NCT07039773 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-17

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are:

* Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration?
* What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges?

Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms.

Participants will be asked to:

* Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart.
* Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours.
* Report any symptoms experienced following each gluten challenge.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vital wheat gluten

Gluten-containing shake vs gluten-containing cookie

DIETARY_SUPPLEMENT

Vital wheat gluten

Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039773 on ClinicalTrials.gov