Food Protein-Induced Enterocolitis Syndrome, Food Protein-Induced Enteropathy, Food Protein-induced Motility Disorders, Food Protein-Induced Proctocolitis, Non IgE Mediated Food Allergy
Conditions
Keywords
Food allergy, Adverse food reactions, Immune tolerance, Atopy patch test, Atopic march, Oral food challenge, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food protein-induced motility disorders
Brief summary
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.
Interventions
OTHERNon IgE-mediated food allergy
Sponsors
Federico II University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of clinical features and disease course of non-IgE mediated food allergies in children | After 72 months from the study start | 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 |
| Evaluation of clinical features of non-IgE mediated food allergies in children | After 72 months from the study start | Dietary management and Nutritional status (weight and height will be combined to report BMI z-score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children | through study completion, an average of 2 years | Evaluation of serum levels of Th2, Th1, and Th17 cytokines |
| Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies | through study completion, an average of 2 years | Evaluation of gut microbiome structure and function |
Countries
Italy
Outcome results
None listed