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NCT Number: NCT04462978

Non-Immunoglobulin E-mediated Food Allergies in Children

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.

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Key information

Conditions

Non IgE Mediated Food Allergy Food Hypersensitivity Food Protein-Induced Enterocolitis Syndrome Food Protein-Induced Enteropathy Food Protein-Induced Proctocolitis Food Protein-induced Motility Disorders Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

1 day–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

Location status: Recruiting

Location contact

Roberto Berni Canani, MD, PhD

CONTACT

+390817462680

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non IgE-mediated food allergy

Other

Primary outcomes

  1. Evaluation of clinical features and disease course of non-IgE mediated food allergies in children

    Time frame: 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

  2. Evaluation of clinical features of non-IgE mediated food allergies in children

    Time frame: After 72 months from the study start

    Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)

Secondary outcomes

  1. Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

    Time frame: through study completion, an average of 2 years

    Evaluation of serum levels of Th2, Th1, and Th17 cytokines

  2. Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

    Time frame: through study completion, an average of 2 years

    Evaluation of epigenetic mechanisms

  3. Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

    Time frame: through study completion, an average of 2 years

    Evaluation of immune cells phenotype

  4. Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

    Time frame: through study completion, an average of 2 years

    Evaluation of mithocondrial metabolism of human lymphocytes

  5. Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies

    Time frame: through study completion, an average of 2 years

    Evaluation of gut microbiome structure and function

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age

Acronym: NIGEFA

Important dates

Study start
2017
Primary completion
2023
Study completion
2027
First posted
Jul 8, 2020
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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