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Wheat sensitivity: a lifelong sentence or just a phase?

NCT ID NCT02823522

Knowledge-focused Sponsor: University of Palermo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 280 people previously diagnosed with non-celiac wheat sensitivity to see if they still needed to avoid wheat years later. Researchers used questionnaires and, in some cases, a double-blind wheat challenge to confirm if symptoms returned. The goal was to understand whether this condition is permanent or can resolve over time.

What this could mean

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

What this could lead to
If successful, this study could clarify whether non-celiac wheat sensitivity is a lifelong condition or something people can outgrow.
What could go wrong
This is an observational follow-up, not a treatment trial, so it won't test any new therapy. Results may not apply to all people with similar symptoms.

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.

Participants

280 people

The number who actually took part.

Started

Jul 2016

Finished

Dec 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.

Who is studied

The patients included in the previous retrospective study were contacted by phone, mail and e-mail and invited to come back to the respective clinics where they had been initially diagnosed as NCWS patients: the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca.

Ages

18 to 65 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: * Patients previously diagnosed with NCWS by DBPC challenge. Exclusion Criteria: * The 22 patients, included in the previous study, who tested positives for anti-endomysial antibodies (EmA) in the culture medium of the duodenal biopsies, even if the villi/crypts ratio in the duodenal mucosa was normal, were excluded from the present study.

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As listed by the trial registrant

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

Non celiac wheat sensitivity

Contacts and locations

Locations

  • Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

    Sciacca, Agrigento, 92019, Italy

  • Department of Internal Medicine, University Hospital of Palermo

    Palermo, Palermo, 90129, Italy

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