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Abstract Atopic dermatitis has been well recognized for its major health burden, which seems to be proportional to gross domestic product, affecting up to 20% of children and 10% of adults. Extensive research revealed a complex aetiopathogenesis of the disease, where gut microbiome would play an underpinning role into the development and course of the disease. Gut dysbiosis, as shown by lower diversity, increased pathobionts and decreased relative abundance of short chain fatty acid producers, has been reproducibly demonstrated in patients with AD. In view of the chronic relapsing nature of the disease and subsequently the need for repetitive courses of topical and systemic therapies with their recognized local and systemic adverse effects, there has been a long pursuit for safe and inexpensive alternative therapeutic options. In this context, modulating gut microbiome, is a potential therapeutic target and is currently under extensive research. Probiotics have been utilized in many clinical trials for the management of AD with promising results. However, there has been inconsistency between different studies on the duration of treatment, probiotic strains administered, age of the recipient patients and whether probiotics were used as adjunctive therapy to steroids, which might explain the difference in clinical outcome. This study is a prospective controlled pilot study to define microbiome patterns in patients with AD and to explore the therapeutic potential of probiotics as a solo treatment conducted on an Egyptian cohort of patients with moderate to severe AD. To the best of our knowledge, this is the first study to investigate the feasibility of utilization of probiotics as a solo treatment of acute exacerbation of AD in a head-to-head comparison with systemic steroids. After ethical approval, patients with SCORAD score ≥ 25 were allocated to either tapering course of steroids, starting at 0.5 mg/kg or probiotics (a mixture of 2 lactobacilli strains; Lactobacillus delbruekii and lactobacillus fermentum at a dose of 1 X 109 CFU twice daily for 3 weeks. Initially, 29 patients were enrolled for the trial (15 allocated to steroid, and 14 to probiotic). Ten patients in total dropped out throughout the study course with 19 patients left to final per-protocol analysis (11 in probiotic group and 8 in steroid group). After 3 weeks of intervention, patients were assessed for clinical improvement (as primary outcome) based on the change in SCORAD index. Patients provided stool samples at baseline and after treatment in both groups for gut microbiome assessment, via 16s rRNA sequencing, to explore any underpinning microbiome changes that might contribute to potential clinical improvement (as a secondary outcome). |