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NCT Number: NCT07039773

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

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Dyskinesias Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Tremor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lovisenberg Diakonale Hospital, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18-33 kg/m2
  • Willingness to comply with the study procedure and having signed informed, written consent
  • Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .
  • Strict adherence to a gluten-free diet at least the 12 last months.

Exclusion criteria

  • Positive serology (IgA-TG2 below upper level of normal) at screening visit
  • Pregnancy or breast feeding. Fertile women must use effective contraception.
  • Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study
  • Using of immunosuppressive/steroid medications
  • Wheat allergy
  • Severe acute infection

Treatment and study plan

Vital wheat gluten

Dietary Supplement

Gluten-containing shake vs gluten-containing cookie

Primary outcomes

  1. Comparison of serum IL-2 response rates between the gluten shake group and the cookie group

    Time frame: From baseline to 4 hours at visit 1

    A responder is defined as an individual exhibiting a log-transformed cytokine level equal to or greater than 0. This level corresponds to 1.0 pg/ml in concentration of IL-2 in serum. The hypothesis is that there is a higher proportion of responders in the gluten shake group compared to the cookie group.

Secondary outcomes

  1. Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2

    Time frame: From baseline to 6 hours after gluten intake

  2. Correlation between serum IL-2 response levels and baseline number of gluten-specific T cells

    Time frame: From baseline to 6 hours after gluten intake

  3. Correlation between serum IL-2 response levels and symptom severity

    Time frame: From baseline to 6 hours after gluten intake

  4. Comparison of serum IL-2 response levels and serum gluten peptide levels

    Time frame: From baseline to 6 hours after gluten intake

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration

Acronym: SHAKE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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