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Could a nickel allergy explain your Child's stomach pain?

NCT ID NCT07105865

Knowledge-focused Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study looks at children with functional gut disorders, like stomach pain or irritable bowel syndrome, to see how many are also allergic to nickel or certain plant proteins called LTPs. Researchers will test for these allergies and also check in the lab whether a supplement called Chelanik can calm the immune cells of children with nickel allergy. The goal is to understand whether these hidden allergies might be driving gut symptoms.

What this could mean

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

Active substance
Chelanik, a dietary supplement for nickel hypersensitivity, tested in the lab on blood cells
What this could lead to
If common, these allergies could point to a dietary trigger for some children's gut symptoms, and Chelanik might offer a way to calm the immune response.
What could go wrong
This is a small, early study. It only tests the supplement on cells in a lab, not on patients, so any benefit for real-world symptoms remains unproven.

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

About 100 people

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

Started

Jul 2025

Expected to finish

Jul 2027

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.

Who is studied

50 adults (\>18 years) and 50 pediatric (4-17 years), of both sexes, belonging to the Adult Gastroenterology Programs and Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II).

Ages

4 to 65 years

Sex

Anyone

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: * Age at least of 4 years * both sexes * history of functional dyspepsia (according to the Rome IV criteria, at least one symptom among the following - duration of symptoms greater than 4 days per month and for more than 2 consecutive months, feeling of post-prandial fullness, early satiety, pain and/or epigastric burning not associated with defecation - in the absence of organic disease) and irritable bowel syndrome (according to the Rome IV criteria, including all of the following criteria for at least 2 months prior to diagnosis - abdominal pain for at least 4 days per month associated with one/more of the following: change in EF, change in stool shape/appearance, if constipation is noticed, pain does not resolve with resolution of constipation - in the absence of organic disease). * written informed consent from the parents of the participants and the participants if over 6 years of age. Exclusion Criteria: * Age \< 4 years * Evidence of gastrointestinal pathology of organic nature (GERD, Helicobacter Pylori infection, eosinophilic diseases, celiac disease, chronic inflammatory bowel disease, chronic pancreatitis, cholelithiasis, neoplasia); motility disorder on a post-infectious basis; food intolerances (e.g. lactose), carbohydrate malabsorption, use of ASAs, NSAIDs; chronic systemic diseases (diabetes, amyloidosis, neuropathy) and autoimmune diseases; neuropsychiatric disorders; pregnancy.

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Conditions

The condition(s) this trial relates to.

dyspepsia food allergy irritable bowel syndrome

As listed by the trial registrant

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

Food allergy in children

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Department of Traslational Medical Science - University of Naples Federico II

    RECRUITING

    Naples, Naples, 80131, Italy

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