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Non-Immunoglobulin E-mediated Food Allergies in Children (NIGEFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462978
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, MD, PhD, Federico II University

Study Description
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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.


Condition or disease Intervention/treatment
Non IgE Mediated Food Allergy Food Protein-Induced Enteropathy Food Protein-Induced Proctocolitis Food Protein-Induced Enterocolitis Syndrome Food Protein-induced Motility Disorders Other: Non IgE-mediated food allergy

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 28, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Non IgE-mediated food allergy
Children with non IgE-mediated food allergy
 Other: Non IgE-mediated food allergy


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Stool samples Peripheral blood samples

Eligibility Criteria
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Ages Eligible for Study:   1 Day to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462978


Locations
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Italy
University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani, MD, PhD    +390817462680      
Sponsors and Collaborators
Federico II University
More Information
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Responsible Party: Roberto Berni Canani, MD, PhD, Professor of Pediatrics, Federico II University
ClinicalTrials.gov Identifier: NCT04462978    
Other Study ID Numbers: 102/20
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto Berni Canani, MD, PhD, Federico II University:
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
Additional relevant MeSH terms:
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Enterocolitis
Intestinal Diseases
Proctocolitis
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colitis
Proctitis
Colonic Diseases
Sigmoid Diseases
Rectal Diseases