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Could your family history of celiac disease hide a wheat sensitivity?

NCT ID NCT07584473

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study aims to find out how many relatives of people with celiac disease have non-celiac wheat sensitivity (NCWS) or other gut issues like IBS. Participants will follow a strict wheat-free diet for 6 weeks and report their symptoms. The goal is to better understand the link between family history and wheat-related problems.

What this could mean

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

Active substance
Wheat-Free Diet
What this could lead to
If successful, this could help identify undiagnosed wheat sensitivity in families with celiac disease, leading to better dietary advice.
What could go wrong
This is an observational study without a control group, so results may not apply to everyone. The diet is short-term and relies on self-reported 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.

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 600 people

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

Started

Apr 2026

Expected to finish

Apr 2028

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 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 * CD patient's relatives * \>18 years old * reporting IBS/FD-like and extraintestinal (EI) symptoms Exclusion criteria * self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes; * drug and/or alcohol (\>30 g/day for men and \>20 g/day for women) abuse; * treatment with steroids and/or non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy; * pregnancy or breastfeeding; * diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.

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Conditions

The condition(s) this trial relates to.

celiac disease dyspepsia functional gastric disease irritable bowel syndrome

As listed by the trial registrant

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

Celiac disease Functional dyspepsia IBS - irritable bowel syndrome Non celiac wheat sensitivity

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

  • Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo

    RECRUITING

    Palermo, PA, 90127, Italy

  • Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo

    RECRUITING

    Palermo, PA, 90146, Italy

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