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临床试验/NCT07308288
NCT07308288已完成不适用

ImmuneNutrition Against Pediatric Respiratory Allergies: Results From the INAPRA Trial

Federico II University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
change in respiratory symptom control

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of asthma and/or allergic rhinitis

排除标准

  • 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.

研究组 & 干预措施

Study product

Experimental

Intervention

干预措施: AllergySTOP (Dietary Supplement)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Other)

结局指标

主要结局

change in respiratory symptom control

时间窗: 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.

次要结局

  • 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)(at abseline)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Berni Canani, MD, PhD

Full professor

Federico II University

研究点 (1)

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