Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
NCT ID: NCT07039773
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-08-01
2026-12-31
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Gluten shake
Liquid form
Vital wheat gluten
Gluten-containing shake vs gluten-containing cookie
Vital wheat gluten
Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa
Gluten cookie
Solid form
Vital wheat gluten
Gluten-containing shake vs gluten-containing cookie
Vital wheat gluten
Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa
Interventions
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Vital wheat gluten
Gluten-containing shake vs gluten-containing cookie
Vital wheat gluten
Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Lovisenberg
UNKNOWN
Oslo University Hospital
OTHER
Responsible Party
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Knut E. A. Lundin
Senior consultant, professor
Locations
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Oslo University Hospital
Oslo, Oslo County, Norway
Lovisenberg Diakonale Hospital
Oslo, Oslo County, Norway
Countries
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Facility Contacts
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References
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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.
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.
Other Identifiers
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24/27476
Identifier Type: -
Identifier Source: org_study_id
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