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NCT07308288Completed

Immune Nutrition in Pediatric Respiratory Allergy

ImmuneNutrition Against Pediatric Respiratory Allergies: Results From the INAPRA Trial

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
15 Dec 2025
Start date
1 Jun 2025
Primary completion date
31 Dec 2025
Lead sponsor
Federico II University
Diseases
Asthma
NCT number
NCT07308288

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 1 Jun 2025 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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,

Other illness

  • known hypersensitivity to any of the ingredients of the study product,
  • the presence of chronic systemic diseases,
  • any condition deemed by the investigators to interfere with study participation or study outcomes.

Age

  • age \<5 or \>12 years,

Other

  • non-Caucasian ethnicity,
  • immunodeficiencies,
  • participation in other studies,

Who the study is looking for

  • confirmed diagnosis of asthma and/or allergic rhinitis

Age in the registry: 5 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Programma Infradipartimentale di Allergologia Pediatrica
Coordinator of this site? Confirm its status
NaplesItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.