Allergic diseases are rising globally. By 2025, over half of the European population is projected to be affected by some form of allergy, with the highest rates among infants and young children. This growing prevalence also has a significant economic impact, resulting in more than 100 million lost work and school days each year due to allergic conditions. Allergies arise from a breakdown in immune tolerance mechanisms. Current research suggests that the development is influenced by genetic, environmental, and gene-environment interactions, leading to immune system dysfunction, partly mediated by epigenetic mechanisms. Various factors have been proposed as contributors to FA onset. Among the unchangeable risk factors are male sex, race/ethnicity (with higher risks among Asian and Black children compared to White children), and genetics (familial associations, HLA, and specific genes). Modifiable risk factors also play a role, with growing evidence showing that environmental influences, such as the use of antibiotics, antiseptic agents, and a high-fat, low-fiber diet, negatively affect microbiome composition. Additional risk factors potentially affecting FA onset include atopic diseases (such as comorbid atopic dermatitis), increased hygiene, vitamin D deficiency, reduced consumption of omega-3 polyunsaturated fatty acids and antioxidants, the use of antacids (which hinder the digestion of allergens), obesity, and the timing and route of food exposure (increased risk with delayed oral ingestion of allergens coupled with environmental exposure). The microbiome also plays a critical role in these processes. Currently, no Food and Drug Administration (FDA)-approved treatment exists for FA, and the standard approach is strict dietary avoidance of the triggering allergens. As a result, the nutritional burden of elimination diets can be substantial, leading to risks such as growth failure, micronutrient deficiencies, and feeding challenges with long-term consequences.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
The nutritional composition of the food supplement comprises: sodium butyrate, inactivated Lactobacillus rhamnosus GG Perilla frutescens dry extract quercetin fructo-oligosaccharides Vitamin D3 omega 3 polyunsaturated acids
Placebo
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, Italy
body growth parameters
body mass index
Time frame: after 6 months of treatment
biochemical values
serum vitamin D levels
Time frame: after 6 months of treatment
biochemical values
serum DHA levels
Time frame: after 6 months of treatment
Cytokines production
Th2 cytokines (IL-4, IL-5, IL-13), IL-10 production
Time frame: after 48 days
regulatory T cells (Tregs) production
regulatory T cells (Tregs)
Time frame: after 4 days
regulatory dendritic cell markers production
regulatory dendritic cell markers (Tgfb1, Ifna2, Ptgs2, Csf2)
Time frame: after 4 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.