Menu
Recruiting NCT07039773

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

No phase Interventional Celiac Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vital wheat gluten, Vital wheat gluten.
Who it may be relevant to
Registry conditions: Celiac Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2 [Time frame: From baseline to 6 hours after gluten intake]
  • 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]
  • Correlation between serum IL-2 response levels and symptom severity [Time frame: From baseline to 6 hours after gluten intake]
  • Comparison of serum IL-2 response levels and serum gluten peptide levels [Time frame: From baseline to 6 hours after gluten intake]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Norway · 2 centers
  • Oslo University Hospital — Oslo
  • Lovisenberg Diakonale Hospital — Oslo

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. PMID 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. PMID 31505020

Identifiers

NCT: NCT07039773 · 24/27476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗