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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 14 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | January 1, 2017 |
| Main results expected | December 30, 2023 |
| Study ends | December 28, 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT04462978 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
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University of Naples Federico II
Naples, Italy Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Finding the best way to diagnose food protein-induced enterocolitis syndrome
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Study of Children With Acute Food Protein Induced Enterocolitis Syndrome
This study is trying to gather information about children with a rare food allergy called FPIES to better understand their symptoms and how the condition changes over time.
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Steroids for allergic reactions to food in children
This study will test whether giving steroids in addition to adrenaline and antihistamines helps children who have allergic reactions during supervised food challenges.
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Tolerance of a hydrolyzed rice-protein baby formula in children with cow's milk allergy.
This will test whether a new hydrolyzed rice-protein formula causes allergic reactions in infants and young children (1–36 months) with IgE-mediated cow's milk allergy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.