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Non-Immunoglobulin E-mediated Food Allergies in Children

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 1 Day - 14 Years
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Federico II University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food Protein-induced Motility Disorders
Arms & Interventions


: Non IgE-mediated food allergy

Children with non IgE-mediated food allergy


Other: - Non IgE-mediated food allergy

Contact a Trial Team

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International Sites

University of Naples Federico II, Naples, Italy




University of Naples Federico II

Naples, , 80131

Site Contact

Roberto Berni Canani, MD, PhD


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