Abstract
The aim of this study was to evaluate the therapeutic efficacy of a comprehensive treatment approach in infants with moderate-to-severe eczema complicated by polyvalent allergic sensitisation. The methodology involved a randomised controlled trial that included 87 children aged 3 to 12 months. Participants were divided into two groups. The experimental group received combined therapy comprising pseudoceramides, a calcineurin inhibitor, and an oral synbiotic, while the control group received standard therapy with emollients and antihistamines. The results demonstrated that by the eighth week, patients in the experimental group exhibited a reduction in SCORAD index of more than 60% (to 21.4 ± 6.5); a 2.7-fold decrease in pruritus severity according to the VAS scale (to 2.9±1.3); and a 61% reduction in POEM score (to 7.3). This was accompanied by improved sleep, reduced irritability, and decreased behavioural disturbances. The control group showed less-pronounced positive dynamics. Immunological changes included a significant decrease in total and specific IgE levels, as well as a marked reduction in IL-4 and IL-13 concentrations, indicating attenuation of the Th2-mediated immune response. The prevalence of severe sensitisation decreased by 20%. Microbiota analysis demonstrated increased Bifidobacterium spp. abundance (+89%; p = 0.011); higher alpha-diversity (Shannon index + 27%; p = 0.004); and reduced E. coli levels (−36%; p = 0.018), suggesting restoration of microbial balance. Thus, this combined therapy demonstrated significant superiority, providing clinical improvement, suppression of the Th2 response, and normalisation of gut microbiota in infants with atopic dermatitis and multiple allergic sensitisation.