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Non-Immunoglobulin E-mediated Food Allergies in Children

Study acronym: NIGEFA
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study completion date: Dec 28, 2025 to Dec 28, 2027v3
  2. Enrollment target: 80 to 150v2 Show 7 more changesShow less
    • Primary completion date: Apr 30, 2018 to Dec 30, 2023
    • Primary endpoints: 4 to 2
    • Trial status: Completed to Recruiting
    • Study completion date: May 28, 2020 to Dec 28, 2025
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 6 to 5
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04462978
Lead Sponsor Federico II University
Conditions
(from sponsor)		 Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food Protein-induced Motility Disorders
Related terms Food Hypersensitivity
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov