Exploratory pilot trial of a multicomponent immunonutritional supplement in children with allergic asthma and rhinitis: The INAPRA study
Abstract
BACKGROUND
Allergic asthma and allergic rhinitis (AR) are among the most frequent chronic conditions in the pediatric age. They frequently coexist in children and are sustained by type 2- driven airway inflammation and impaired epithelial-immune interactions. Immunonutritional and postbiotic strategies have been proposed as adjunctive therapeutic approaches for these diseases.
OBJECTIVE
To explore the clinical and immunomodulatory potential of a multicomponent immunonutritional supplement containing postbiotics in children with concomitant allergic asthma and AR.
METHODS
The ImmuneNutrition Against Pediatric Respiratory Allergies (INAPRA) study was a multicenter, randomized, double-blind, placebo-controlled exploratory pilot trial. Forty children aged 5-12 years with asthma and AR sensitized to Dermatophagoides pteronyssinus were randomized (1:1) to receive a daily multicomponent supplement (sodium butyrate, heat-inactivated L. rhamnosus GG, fructooligosaccharides, vitamin D3, docosahexaenoic acid, quercetin, and Perilla frutescens extract) or placebo for 6 months. Co-primary outcomes were changes in respiratory symptom control assessed by Childhood Asthma Control Test (c-ACT), CARATkids, and Total Nasal Symptom Score (TNSS). Secondary outcomes included cytokine production, regulatory T-cell rate and tolerogenic gene expression (gfb1, Ptgs2, Csf2, and Ifna2) in peripheral blood mononuclear cells (PBMCs). Immunological assays were performed in vitro on PBMCs collected before…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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