International immunopharmacology · 2026
Exploratory pilot trial of a multicomponent immunonutritional supplement in children with allergic asthma and rhinitis: The INAPRA study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Caldaria Erika, Iorio Raffaele, Marziali Dario, Oglio Franca, Cadavere Alessia, Masino Antonio, Agizza Alessandra, Coppola Serena, Carucci Laura
Аннотация
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 intervention.
RESULTS: Baseline clinical characteristics were comparable between groups. In baseline-adjusted analyses, children receiving the study product showed more favorable 6-month outcomes than those receiving placebo across all three prespecified symptom-control measures. The adjusted between-group difference was 4.625 points (95% CI 3.705 to 5.545; p < 0.001) for c-ACT and - 3.960 points (95% CI -4.890 to -3.030; p < 0.001) for TNSS. For CARATkids, a significant treatment-by-baseline interaction was detected; at the mean baseline score, the adjusted conditional between-group difference was -7.019 points (95% CI -8.143 to -5.895; p < 0.001). The use of rescue medications was higher in the placebo group. No adverse events related or unrelated to the study product were reported, and adherence exceeded 90%. In in vitro experiments, co-incubation with the study product attenuated allergen-induced Th2 cytokine secretion (IL-4, IL-5, IL-13), increased IL-10 production, enhanced CD4+CD25+FoxP3+ regulatory T-cell rate, and upregulated Tgfb1, Ptgs2, Csf2, and Ifna2 expression.
CONCLUSIONS: In this exploratory pilot RCT, six-month supplementation with a multicomponent immunonutritional formulation was associated with improvement of allergic asthma and rhinitis control in children. The clinical improvement paralleled with beneficial modulatory actions in immune cells.
, TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT07308288.
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 intervention.
RESULTS: Baseline clinical characteristics were comparable between groups. In baseline-adjusted analyses, children receiving the study product showed more favorable 6-month outcomes than those receiving placebo across all three prespecified symptom-control measures. The adjusted between-group difference was 4.625 points (95% CI 3.705 to 5.545; p < 0.001) for c-ACT and - 3.960 points (95% CI -4.890 to -3.030; p < 0.001) for TNSS. For CARATkids, a significant treatment-by-baseline interaction was detected; at the mean baseline score, the adjusted conditional between-group difference was -7.019 points (95% CI -8.143 to -5.895; p < 0.001). The use of rescue medications was higher in the placebo group. No adverse events related or unrelated to the study product were reported, and adherence exceeded 90%. In in vitro experiments, co-incubation with the study product attenuated allergen-induced Th2 cytokine secretion (IL-4, IL-5, IL-13), increased IL-10 production, enhanced CD4+CD25+FoxP3+ regulatory T-cell rate, and upregulated Tgfb1, Ptgs2, Csf2, and Ifna2 expression.
CONCLUSIONS: In this exploratory pilot RCT, six-month supplementation with a multicomponent immunonutritional formulation was associated with improvement of allergic asthma and rhinitis control in children. The clinical improvement paralleled with beneficial modulatory actions in immune cells.
, TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT07308288.