Clinical trial Recruiting at 1 site Observational Ages 1 Day to 14

Understanding Non-IgE-mediated Food Allergies in Children

Official title: Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age

Run by Federico II University · NCT04462978 · Data updated 2026-11-12

This study is trying to learn more about non-IgE-mediated food allergies in children, like certain gastrointestinal issues, to help improve how these allergies are understood and managed.

More Food Protein-Induced Enterocolitis Syndrome trials

Quick facts

Study typeObservational
Ages1 Day to 14 Years
SexAll
Enrollment150 (estimated)
SponsorFederico II University
Academic / other
Locations1 site (Naples)
StatusRecruiting
StartedJanuary 1, 2017
Main results expectedDecember 30, 2023
Study endsDecember 28, 2027
Registry record updatedSeptember 2, 2026
Trial IDNCT04462978 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 0-14 years with a history suggestive of food allergies.

Probably not a fit

Patients over the age of 14 or those with chronic systemic diseases or other specified exclusions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on non-IgE-mediated gastrointestinal food allergies in children, which include conditions like food protein-induced enterocolitis syndrome and food protein-induced enteropathy. The study aims to evaluate the clinical features, natural history, and pathophysiology of these food allergies in the pediatric population. By gathering data on these conditions, the research seeks to improve understanding and management of non-IgE-mediated food allergies, which are often poorly defined and can lead to diagnostic delays. The study will involve children aged 0-14 years who have a suggestive history of food allergies.

Why it matters

Potential benefit: If successful, this study could lead to better diagnosis and management strategies for children suffering from non-IgE-mediated food allergies.

How similar studies have gone: While there is limited research specifically on non-IgE-mediated food allergies, similar studies on food allergies have shown promise in improving understanding and management.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Naples Federico II
    Naples, Italy
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.