Efficacy and Safety of Lactobacillus rhamnosus GG Supplementation in Children with Atopic Dermatitis: A Prospective Open-label Single-arm Uncontrolled Study

Introduction: Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disorder characterized by pruritus, xerosis, and eczematous lesions, commonly beginning in early childhood. It is postulated that dysbiosis of the gut microbiota may contribute to immune dysregulation along the gut–skin axis, promoting Th2/Th22-driven inflammation. In this context, probiotic supplementation has been often proposed as an adjunctive therapeutic strategy. However, there are inadequate data about the efficacy and safety of probiotic supplementation, especially from the Indian subcontinent. In this study, we evaluated the clinical efficacy and safety of Lactobacillus rhamnosus GG (LRGG) supplementation in pediatric AD. Methodology: This prospective observational study was conducted among 765 children aged 2–18 years with mild-to-moderate AD diagnosed by Hanifin and Rajka’s diagnostic criteria. Patients received age-adjusted oral LRGG (6 × 10 9 CFU per sachet; one sachet daily <12 years, two ≥12 years) for 6 weeks – 6 months, alongside standard topical therapy. Disease severity was assessed by SCORing AD (SCORAD) and Eczema Area and Severity Index (EASI) indices at baseline, 6 weeks, 3 months, and 6 months. Clinical improvement was defined as ≥30% SCORAD reduction. Safety and adverse effects were recorded at each follow-up. Statistical analysis used paired t -tests and Chi-square tests, with P < 0.05 considered statistically significant. Results: The cohort comprised 408 boys (53.3%) and 357 girls (46.7%) with mean age of 9.8 ± 4.2 years. Mean baseline SCORAD and EASI were 35.2 ± 10.6 and 15.1 ± 5.2, respectively. Progressive improvement was observed across all visits: SCORAD declined to 15.9 ± 7.3 and EASI to 6.9 ± 3.2 at 6 months ( P < 0.001). By the end of the study, 74.3% achieved ≥30% SCORAD reduction, 61.7% attained EASI-50, and 41% EASI-75. Response was greatest in children 2–6 years (EASI-50 = 67.5% and EASI-75 = 47.8%) and least in adolescents 13–18 years (EASI-50 = 48.7% and EASI-75 = 26.7%). Pruritus decreased in 46% and sleep disturbance in 38% of participants. No adverse effects were reported. Conclusion: Oral LRGG supplementation significantly improved clinical severity, pruritus, and sleep quality in pediatric AD, particularly among younger and milder cases, with excellent safety and tolerability. Probiotics may serve as a valuable, low-cost adjunct to conventional therapy in resource-limited settings. Further randomized controlled trials are warranted to define optimal probiotic strains, dosing, and long-term efficacy.