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Can we decode the hidden food allergies that Don't show up on standard tests?

NCT ID NCT04462978

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study follows children aged 0 to 14 with suspected non-IgE food allergies, which cause digestive symptoms like reflux, colic, or constipation rather than immediate allergic reactions. Researchers will track symptoms, triggers, and growth over time, and analyze blood samples to explore immune system patterns. The goal is to better understand how these conditions develop and progress, which could improve diagnosis and care.

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 research could clarify how non-IgE food allergies develop and progress, leading to faster diagnosis and better management strategies for affected children.
What could go wrong
This is an observational study, so it will not test a treatment. Findings may not apply to all children, and the causes of these allergies may remain complex and unclear.

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 150 people

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

Started

Jan 2017

Expected to finish

Dec 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

subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged between 0-14 years with suggestive history of food allergy

Ages

1 day to 14 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * subjects aged between 0-14 years * suggestive history of food allergy Exclusion Criteria: * age \>14 years- * chronic systemic diseases, * malignancy, * immunodeficiency, * infectious diseases, * autoimmune diseases, * inflammatory bowel diseases, * celiac disease, * metabolic and genetic diseases, * cystic fibrosis, * chronic pulmonary diseases, * gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations, * neurologic and/or neuropsychiatric disorders, * gastrointestinal tract eosinophilic disorders, * use of immunomodulating drugs, steroids, pre-pro-synbiotics, antibiotics in the previous 4 months

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Conditions

The condition(s) this trial relates to.

food allergy food protein-induced allergic proctocolitis food protein-induced enterocolitis syndrome

As listed by the trial registrant

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

Food protein-induced enterocolitis syndrome Food protein-induced enteropathy Food protein-induced motility disorders Food protein-induced proctocolitis Non IgE mediated food allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    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

  • University of Naples Federico II

    RECRUITING

    Naples, 80131, Italy

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