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RecruitingNCT07039773SHAKEUpdated Apr 17, 2026

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

An interventional study of Vital wheat gluten and Vital wheat gluten in Celiac Disease, sponsored by Oslo University Hospital. Recruiting at 2 sites in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.
02

Conditions studied

  • Celiac Disease

Keywords

  • Gluten challenge
  • Interleukin-2
  • Shake
  • Cookie
  • T cells
  • Whole blood cytokine release assay
  • GI Symptoms
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Gluten shake

    Liquid form

    Dietary Supplement: Vital wheat gluten

  • Active comparator
    Gluten cookie

    Solid form

    Dietary Supplement: Vital wheat gluten

Interventions

  • Dietary supplementVital wheat gluten

    Gluten-containing shake vs gluten-containing cookie

  • Dietary supplementVital wheat gluten

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

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: From baseline to 4 hours at visit 1

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

06

Study locations

2 of 2 sites recruiting
  • Oslo University Hospital
    Oslo, Oslo 0372, Norway
    • Stine R Lund · Contact · coliaki@ous-hf.no · +47 230 72 403
    • Knut E A Lundin, MD, PhD · Principal investigator
    • Louise F Risnes, PhD · Sub investigator
    • Jostein H Ibsen, MD · Sub investigator
    Recruiting
  • Lovisenberg Diakonale Hospital
    Oslo, Oslo 0456, Norway
    • Anita Tollisen, PhD · Contact · coliaki@ous-hf.no · +4723225140
    • Jørgen Valeur, MD, PhD · Principal investigator
    Recruiting
07

References and documents

Publications

  • Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y. PubMed 33239013 ↗
  • 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. PubMed 31505020 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07039773
Lead sponsor
Oslo University Hospital
Responsible party
Knut E. A. Lundin (Senior consultant, professor, Oslo University Hospital) — Principal investigator
First posted
Jun 26, 2025
Start date
Aug 1, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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