NCT07308288: INAPRA

Immune Nutrition in Pediatric Respiratory Allergy

Completed NA Last updated 17 February 2026

What this trial tests

NA trial testing AllergySTOP in Asthma Acute in 40 participants. Completed in 31 December 2025.

Timeline

1 June 2025

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Federico II University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 June 2025
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across Italy

Drugs / interventions tested

• AllergySTOP
• Placebo

Conditions studied

• Asthma Acute — all drugs for Asthma Acute →
• Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Federico II University

Who can join

Adults 5 to 12, any sex, with Asthma Acute or Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploratory pilot trial of a multicomponent immunonutritional supplement in children with allergic asthma and rhinitis: The INAPRA study.
   Caldaria E, Iorio R, Marziali D, Oglio F, et al · · 2026 · PMID 42202393 · DOI 10.1016/j.intimp.2026.116903