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Gluten-Free diet tested for ulcerative colitis relief

NCT ID NCT06249763

Symptom relief Sponsor: University of Southern Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether eating gluten-free for one week reduces gut symptoms and fatigue in people with ulcerative colitis. Fifteen participants followed both a high-gluten and a gluten-free diet in random order, with symptom questionnaires and samples collected. The goal is to see if some people feel better without gluten and what might make them different.

What this could mean

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

Active substance
gluten
What this could lead to
If it works, this could point toward a dietary approach to manage symptoms in some people with ulcerative colitis.
What could go wrong
This is a very small, short-term trial (15 people, 1 week per diet) and results may not apply to everyone. It only looks at symptoms, not disease progression.

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

15 people

The number who actually took part.

Started

Mar 2024

Finished

Oct 2024

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: * Diagnosis: Ulcerative Colitis (UC) * Language: Can read and understand Danish * Treatment: No intention to change dose of, begin, or switch medication and biologic treatment within one month after inclusion * Treatment: Medical and/or biologic treatment type and dose stable for at least 8-16 weeks prior to inclusion depending on the type of treatment Exclusion Criteria: * Age: \<18 years * Severe disease activity defined by 6 or more bloody stools per day and/or night and one of the following: fever, pulse ≥ 90, C-reactive protein (CRP) ≥ 30mg/L by the time of inclusion * Treatment: Have received antibiotic treatment within 4 weeks prior to inclusion * Treatment: Previous operation for UC * Concomitant diagnoses: Coeliac Disease (positive Immunoglobolin A against transglutaminase, TGA-IgA) or any cancer diagnosis * Other: Taking probiotics, are pregnant or breastfeeding, or have nut or wheat allergy

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Conditions

The condition(s) this trial relates to.

Fatigue inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflammatory bowel diseases Ulcerative colitis

Contacts and locations

Locations

  • Hospital of Southern Jutland

    Aabenraa, Denmark, 6200, Denmark

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