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New gluten challenge study aims to make 'Gluten-Free' labels safer

NCT ID NCT06151782

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

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed study from Oslo University Hospital involved 33 adults with celiac disease who followed a strict gluten-free diet. Over five separate one-day challenges, participants consumed wheat gluten, barley gluten, hydrolyzed barley gluten, or a placebo. Researchers measured immune responses in the blood and gluten fragments in urine and stool to see which forms of gluten trigger reactions. The goal was to develop better analytical methods to assess the safety of partially hydrolyzed gluten in food products for celiac patients.

What this could mean

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

Active substance
gluten (wheat and barley, including hydrolyzed barley)
What this could lead to
If successful, this could lead to better methods for testing whether processed gluten-containing ingredients are safe for people with celiac disease.
What could go wrong
This was a small, early-stage study with only 33 participants, and the results may not apply to all celiac patients or all gluten-containing products.

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

33 people

The number who actually took part.

Started

Jan 2024

Finished

Jun 2025

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 years and older

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 between 18 and 30 kg/m2 * Biopsy verified celiac disease * Pos gene test for HLA-DQ2.5 or DQ8 * Strict glutenfree diet for at least 24 months * Clinical remission * Sensitive to gluten by accidental intake * Effective contraception if female in fertile age Exclusion Criteria: * Positive serology at screening * Pregnant or lactating * Other disease like Type 1 diabetes, cardiovascular disease, cancer, inflammatory bowel disease, thyroid or kidney disease * On immunosuppressive drugs * Smoking * Food allergy including wheat allergy * Acute infection

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Conditions

The condition(s) this trial relates to.

celiac disease Food Intolerance

As listed by the trial registrant

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

Celiac disease Food intolerance

Contacts and locations

Locations

  • Clinical Center for Celiac Disease and Autoimmunity

    Mainz, Germany, 55131, Germany

  • Dept of Gastroenterology

    Oslo, Oslo, 0881, Norway

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