Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07039773

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

Led by Oslo University Hospital · Updated on 2026-04-17

30

Participants Needed

2

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index between 18 and 33 kg/m2
  • Willingness to follow study procedures and sign informed consent
  • Previous diagnosis of celiac disease based on positive blood tests and duodenal biopsy showing villous atrophy
  • Strict adherence to a gluten-free diet for at least the last 12 months
Not Eligible

You will not qualify if you...

  • Positive serology (IgA-TG2 above normal limit) at screening
  • Pregnancy or breastfeeding; fertile women must use effective contraception
  • Other inflammatory diseases such as uncontrolled hypothyreosis, type 1 diabetes, cardiovascular disease, thyroid or kidney disorders, or inflammatory bowel disease
  • Use of immunosuppressive or steroid medications
  • Wheat allergy
  • Severe acute infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Oslo University Hospital

Oslo, Oslo, Norway, 0372

Actively Recruiting

2

Lovisenberg Diakonale Hospital

Oslo, Oslo, Norway, 0456

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here