Transforming Atopic Dermatitis Management: Probiotics as a Game-Changer in Immune Modulation-A Double-Blind, Placebo-Controlled Clinical Trial.

Abstract

Background: Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder characterized by immune dysregulation and microbiota imbalances. It affects millions worldwide, leading to significant morbidity and reduced quality of life. The disease is marked by intense pruritus, xerosis, and eczematous lesions, often accompanied by psychological distress and sleep disturbances. Recent research has established a strong association between gut dysbiosis and AD pathogenesis, suggesting that interventions targeting the gut microbiota may offer therapeutic benefits. Objective: This study aimed to evaluate the effects of a high-dose multistrain probiotic formulation, DSF Formulation®, on disease severity and immune modulation in adult patients with moderate-to-severe AD. Methods: A double-blind, randomized, placebo-controlled trial was conducted, enrolling 80 adult patients diagnosed with AD. Participants were randomly assigned to receive either DSF Formulation® or a placebo for 60 days. Clinical outcomes were assessed using Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI) scoring systems, while immunological parameters were evaluated by measuring cytokine levels (IL-4, IL-10, and TGF-β) via enzyme-linked immunosorbent assay. Results: Probiotic supplementation resulted in a significant reduction in SCORAD, EASI, and DLQI scores compared to the placebo group (P < 0.05). Additionally, a substantial decrease in IL-4 levels was observed in the probiotic-treated group, alongside a significant increase in IL-10 and TGF-β levels (P < 0.05), indicating a shift towards an anti-inflammatory immune response. Conclusion: These findings suggest that DSF Formulation® may serve as an effective adjunctive therapy for AD by modulating the gut microbiota and promoting an anti-inflammatory immune response. Furthermore, studies are warranted to confirm these results, assess long-term clinical implications, and determine the optimal probiotic formulations for therapeutic use.