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OpenTrials
Completed

NCT Number: NCT07308288

Immune Nutrition in Pediatric Respiratory Allergy

Respiratory allergic diseases, namely asthma and allergic rhinitis (AR), are among the most common chronic pediatric conditions with prevalence continuing to rise over last decades and are leading healthcare costs. Epidemiological trends show high rates in young children, aged under 10 years, significant comorbidity between conditions (asthma and AR), and a rising recognition of lifestyle's role in microbial, epithelial barrier and immune system dysfunction which collectively drive type 2-driven airway inflammation, the hallmark feature of allergic respiratory diseases.

Strategies aiming to reduce allergy outcomes have included dietary interventions during the pediatric age with immunonutrition and postbiotics. Immunonutrition uses specific nutrients to support the immune system, while postbiotics use microbial-derived compounds to modulate microbiome, epithelial barrier and immune function, and they can work together by modulating the gut-immune axis to reduce inflammation and to promote immune tolerance also through epigenetic mechanisms.

Vitamin D, DHA, quercetin, perilla frutescens, fructooligosaccharides and DHA have been indicated as promising food supplements for and effective immunonutrition action against allergy. Similarly, postbiotics-non-viable microbial preparations with demonstrated biological activity-such as heat-inactivated Lactobacillus rhamnosus GG (LGG) and the gut microbiome-derived metabolite butyrate have been shown to strengthen epithelial barrier integrity, modulate cytokine secretion, and promote regulatory immune responses.

Collectively, these findings suggest that targeted nutritional or microbial-derived interventions capable of reinforcing epithelial barrier function and restoring regulatory immune pathways may offer a promising adjunctive strategy for pediatric allergic airway diseases. Despite the expanding mechanistic evidence, clinical trials evaluating multi-component immunomodulatory nutritional interventions in children with asthma or allergic rhinitis remain scarce, and the translational relevance of these mechanistic pathways has not yet been thoroughly tested in controlled pediatric studies.

Based on this rationale, we designed a clinical study to evaluate the clinical and immunological effects of a multi-component supplement containing immunonutritional compounds and postbiotics focusing on symptom control and immunoregulatory biomarkers in PBMCs from children with allergic asthma and AR.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Programma Infradipartimentale di Allergologia Pediatrica

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed diagnosis of asthma and/or allergic rhinitis

Exclusion criteria

  • non-Caucasian ethnicity,
  • age <5 or >12 years,
  • known hypersensitivity to any of the ingredients of the study product,
  • the presence of chronic systemic diseases,
  • immunodeficiencies,
  • ongoing allergen immunotherapy,
  • treatment with immunomodulators,
  • systemic corticosteroids, antibiotics, or pre/pro/synbiotics within the four weeks prior to enrollment and during the 6-month study period,
  • participation in other studies,
  • any condition deemed by the investigators to interfere with study participation or study outcomes.

Treatment and study plan

AllergySTOP

Dietary Supplement

Sodium butyrate FOS (Fructooligosaccharides) Vitamin D3 Heat-inactivated L. rhamnosus GG (LGG) DHA Powder Perilla frutescens Quercetin

Placebo

Other

Placebo

Primary outcomes

  1. change in respiratory symptom control

    Time frame: after 6 months

    The primary outcome was the change in respiratory symptom control from T0 to T6, assessed using the c-ACT for asthma, and the CARATkids and TNSS for AR.

Secondary outcomes

  1. assessment in PBMCs of IL-4, IL-5, IL-13, IL-10, regulatory T cells (CD4⁺CD25⁺FoxP3⁺), and the expression of tolerogenic dendritic cell-associated markers (Tgfb1, Ifna2, Ptgs2)

    Time frame: at abseline

    at T0, the assessment of immune responses in PBMCs, specifically cytokine secretion profiles (IL-4, IL-5, IL-13, IL-10), the frequency of regulatory T cells (CD4⁺CD25⁺FoxP3⁺), and the expression of tolerogenic dendritic cell-associated markers (Tgfb1, Ifna2, Ptgs2, Csf2)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

ImmuneNutrition Against Pediatric Respiratory Allergies: Results From the INAPRA Trial

Acronym: INAPRA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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