An observational study in Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy and Food Protein-Induced Proctocolitis, sponsored by Federico II University. Recruiting at 1 site in Italy. Open to participants aged 1 Day to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Federico II University · Observational
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).
Despite the prevalence and clinical impact of these conditions, the pathogenesis as well as the natural history and the best management of these disorders are still poorly defined. These limitations could be responsible for diagnostic delays and errors, and suboptimal clinical management. We aim to evaluate clinical features, natural course and pathophysiology of non-IgE-GIFA in the pediatric age.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 150 is close to the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with non IgE-mediated food allergy
Other: Non IgE-mediated food allergy
Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
Rate of pts affected by FPIES, FPE, FPIAP, FPIMD; diagnostic delay; disease duration, rate of pts with mono vs poli food allergies; main antigens responsible for the diseases; occurrence of atopic dermatitis before food allergy onset; results of allergy screening tests; occurrence of atopic march
Time frame: After 72 months from the study start
Evaluation of clinical features of non-IgE mediated food allergies in children
Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)
Time frame: After 72 months from the study start
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of serum levels of Th2, Th1, and Th17 cytokines
Time frame: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of epigenetic mechanisms
Time frame: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of immune cells phenotype
Time frame: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of mithocondrial metabolism of human lymphocytes
Time frame: through study completion, an average of 2 years
Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies
Evaluation of gut microbiome structure and function
Time frame: through study completion, an average of 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Dec 2023, 83 months.
Of 42 non-industry observational studies under Food Hypersensitivity, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 250. This study's 83 months is above that.
Counting every sponsor, half of 43 studies reached it within 42 months; a quarter within 19 and three quarters within 250.
How these figures are worked out, and which studies are left out of them.
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