deltatrials
Recruiting INTERVENTIONAL NCT07039773

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

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

Sponsor: Oslo University Hospital

Conditions Celiac Disease
Updated 2 times since 2025 Last updated: Apr 14, 2026 Started: Aug 1, 2025 Primary completion: Dec 1, 2026 Completion: Dec 1, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Celiac Disease and is currently actively recruiting participants. Oslo University Hospital leads this study, which shows 2 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2025 – ~Apr 2026 · 10 months · monthly snapshotNot Yet RecruitingApr 18, 2026 – present · 3 months · daily APIRecruiting

Change History

2 versions recorded
  1. Apr 18, 2026 — Present [daily]

    Recruiting

    Status: Not Yet RecruitingRecruiting · Phase: NANone

  2. Jul 2025 — Apr 2026 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Oslo University Hospital
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations