Non-Immunoglobulin E-mediated Food Allergies in Children

NCT ID: NCT04462978

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2025-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Non IgE Mediated Food Allergy Food Protein-Induced Enteropathy Food Protein-Induced Proctocolitis Food Protein-Induced Enterocolitis Syndrome Food Protein-induced Motility Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non IgE-mediated food allergy

Children with non IgE-mediated food allergy

Non IgE-mediated food allergy

Intervention Type OTHER

Interventions

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Non IgE-mediated food allergy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Berni Canani, MD, PhD

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Roberto Berni Canani, MD, PhD

Role: primary

+390817462680

Other Identifiers

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102/20

Identifier Type: -

Identifier Source: org_study_id

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