Dietary Supplements

Exploratory pilot trial of a multicomponent immunonutritional supplement in children with allergic asthma and rhinitis: The INAPRA study.

TL;DR

Six-month supplementation with a multicomponent immunonutritional formulation was associated with improvement of allergic asthma and rhinitis control in children, paralleled by beneficial modulatory actions in immune cells.

Key Findings

Children receiving the multicomponent immunonutritional supplement showed significantly greater improvement in asthma control compared to placebo as measured by the Childhood Asthma Control Test (c-ACT).

  • The adjusted between-group difference for c-ACT was 4.625 points (95% CI 3.705 to 5.545; p < 0.001)
  • 40 children aged 5-12 years were randomized 1:1 to supplement or placebo
  • The intervention lasted 6 months
  • Children were sensitized to Dermatophagoides pteronyssinus
  • Baseline clinical characteristics were comparable between groups

Children receiving the supplement showed significantly greater improvement in nasal symptom control compared to placebo as measured by the Total Nasal Symptom Score (TNSS).

  • The adjusted between-group difference for TNSS was -3.960 points (95% CI -4.890 to -3.030; p < 0.001)
  • Lower TNSS scores indicate better nasal symptom control
  • This was one of three co-primary outcomes in the trial
  • The analysis was baseline-adjusted

Children receiving the supplement showed significantly greater improvement in combined asthma and rhinitis control as measured by CARATkids, with a significant treatment-by-baseline interaction detected.

  • A significant treatment-by-baseline interaction was detected for CARATkids
  • 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 treatment-by-baseline interaction means the magnitude of benefit varied depending on baseline symptom severity
  • CARATkids was one of three co-primary outcomes

Use of rescue medications was higher in the placebo group than in the supplement group.

  • This was reported as a secondary finding supporting the primary symptom-control outcomes
  • The trial was a multicenter, randomized, double-blind, placebo-controlled design
  • No specific numerical data for rescue medication use were provided in the abstract

The multicomponent supplement demonstrated high tolerability and adherence, with no adverse events reported.

  • No adverse events related or unrelated to the study product were reported
  • Adherence to the supplement regimen exceeded 90%
  • The study product was administered daily for 6 months
  • The sample included 40 children aged 5-12 years

In vitro co-incubation of PBMCs with the study product attenuated allergen-induced Th2 cytokine secretion and increased IL-10 production.

  • Co-incubation with the study product reduced allergen-induced secretion of IL-4, IL-5, and IL-13 (Th2 cytokines)
  • IL-10 production was increased following co-incubation with the study product
  • Immunological assays were performed in vitro on PBMCs collected before intervention
  • These were secondary outcomes of the trial

In vitro exposure to the study product enhanced regulatory T-cell rates and upregulated tolerogenic gene expression in PBMCs.

  • Co-incubation with the study product enhanced CD4+CD25+FoxP3+ regulatory T-cell rate
  • Expression of Tgfb1, Ptgs2, Csf2, and Ifna2 was upregulated
  • These four genes were prespecified as secondary outcomes (listed in the abstract as gfb1, Ptgs2, Csf2, and Ifna2)
  • Experiments were conducted on PBMCs collected at baseline before intervention began

The multicomponent supplement contained seven active ingredients targeting immunonutritional and postbiotic pathways.

  • Ingredients included sodium butyrate, heat-inactivated L. rhamnosus GG (postbiotic), fructooligosaccharides (prebiotic), vitamin D3, docosahexaenoic acid (DHA), quercetin, and Perilla frutescens extract
  • The supplement was administered daily for 6 months
  • The formulation was designed to target type 2-driven airway inflammation and impaired epithelial-immune interactions
  • The study population had concomitant allergic asthma and allergic rhinitis sensitized to house dust mite (Dermatophagoides pteronyssinus)

What This Means

This research suggests that a daily nutritional supplement containing a mix of gut-health and immune-supporting ingredients — including a postbiotic (heat-killed probiotic bacteria), a short-chain fatty acid (sodium butyrate), a prebiotic fiber, vitamin D, omega-3 fatty acid, quercetin, and a plant extract — may help improve symptom control in children who have both asthma and allergic rhinitis (hay fever-like symptoms). Over six months, children aged 5 to 12 who took the supplement showed meaningfully better scores on standardized tests measuring asthma control and nasal symptom burden compared to children who received a placebo. Children in the placebo group also needed more rescue medications during the study period. Alongside these clinical improvements, laboratory experiments on immune cells (PBMCs) taken from the children before the study began showed that exposing those cells to the supplement ingredients reduced the production of inflammation-promoting immune signals (Th2 cytokines like IL-4, IL-5, and IL-13), increased an anti-inflammatory signal (IL-10), raised the proportion of regulatory T-cells (immune cells that help calm overactive immune responses), and activated genes associated with immune tolerance. This suggests the supplement may work by shifting the immune system away from the allergic inflammatory response. Importantly, no side effects were reported, and more than 90% of participants adhered to the supplement regimen, suggesting it was well tolerated by children. However, this was a small exploratory pilot trial with only 40 participants at a single time point, so these findings are preliminary. Larger confirmatory trials would be needed to establish whether this type of supplement could become a reliable adjunctive approach for managing pediatric allergic asthma and rhinitis.

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Citation

Caldaria E, Iorio R, Marziali D, Oglio F, Cadavere A, Masino A, et al.. (2026). Exploratory pilot trial of a multicomponent immunonutritional supplement in children with allergic asthma and rhinitis: The INAPRA study.. International immunopharmacology. https://doi.org/10.1016/j.intimp.2026.116903