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Shake or cookie? study tests which gluten form triggers stronger immune response in celiac patients

NCT ID NCT07039773

Knowledge-focused Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how people with celiac disease react to gluten in liquid form (a shake) versus solid form (a cookie). Thirty adults on a gluten-free diet will try both, in random order, with blood samples taken to measure immune markers and symptoms. The goal is to see if liquid gluten causes a stronger immune response, which could help improve future testing methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vital wheat gluten (gluten-containing shake and cookie)
What this could lead to
If successful, this could help researchers better understand how the form of gluten affects immune reactions in celiac disease, potentially improving future diagnostic tests.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply to everyone. It is designed to measure immune markers, not to test a treatment, so there is no direct benefit for participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

celiac disease Tremor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lovisenberg Diakonale Hospital

    RECRUITING

    Oslo, Oslo, 0456, Norway

  • Oslo University Hospital

    RECRUITING

    Oslo, Oslo, 0372, Norway

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