Understanding Non-IgE-mediated Food Allergies in Children
Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age
Federico II University · NCT04462978
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 1 Day to 14 Years |
| Sex | All |
| Sponsor | Federico II University (other) |
| Locations | 1 site (Naples) |
| Trial ID | NCT04462978 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-14 years with a history suggestive of food allergies.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Naples
- University of Naples Federico II — Naples, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food Protein-induced Motility Disorders, Food allergy, Adverse food reactions, Immune tolerance