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

NCT07039773 | Recruiting

• 1 other identifier: 24/27476
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Celiac Disease

Keywords

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

Outcome Measures

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.

  From baseline to 4 hours at visit 1

Secondary Outcomes (4)

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

  From baseline to 6 hours after gluten intake

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

  From baseline to 6 hours after gluten intake

• Correlation between serum IL-2 response levels and symptom severity

  From baseline to 6 hours after gluten intake

• Comparison of serum IL-2 response levels and serum gluten peptide levels

  From baseline to 6 hours after gluten intake

Study Arms (2)

Gluten shake

ACTIVE COMPARATOR

Liquid form

Dietary Supplement: Vital wheat gluten

Gluten cookie

ACTIVE COMPARATOR

Solid form

Dietary Supplement: Vital wheat gluten

Interventions

Vital wheat gluten DIETARY_SUPPLEMENT

Gluten-containing shake vs gluten-containing cookie

Gluten cookie; Gluten shake

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Oslo University Hospital

Oslo, Oslo, 0372, Norway

RECRUITING

Lovisenberg Diakonale Hospital

Oslo, Oslo, 0456, Norway

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Celiac Disease; Tremor

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

NO (2)