Evaluating the effect of supplementation with Bacillus clausii on therapeutic outcomes in atopic eczema—Results of an observer-blinded parallel-group randomized controlled study

Background: Atopic dermatitis (AD) is an itchy, chronic or chronically relapsing, inflammatory skin condition. Aims: To study the effectiveness of probiotic supplementation (Bacillus clausii) in achieving clinical remission, preventing relapse and its effect on immunological profile in children with AD. Methods: In this randomized controlled study, 114 children with AD were randomized into two groups (57 each): Group A received conventional treatment, along with Bacillus clausii (Strains O/C, N/R, SIN and T) suspension available as Enterogermina® at the dose 2 billion spores/5 ml twice daily for 8 weeks and Group B receiving conventional treatment only. Baseline and follow-up SCORAD were assessed at 0, 4, 8, 12, 16, 20 and 24 weeks. Serum IL-17A levels were measured at baseline and 12 weeks. Results: There was no significant difference in mean SCORAD between the two groups at baseline, 12 weeks (p = 0.21) and 24 weeks (p = 0.26). The two groups did not differ significantly in terms of the number of patients who achieved SCORAD 90 (p = 0.19), SCORAD 75 (p = 0.59), and those who relapsed (p = 0.5). IL-17A levels were not significantly different between the two groups at baseline and 12 weeks (p = 0.7). There was no statistically significant correlation between IL-17A levels and AD severity. Limitations: Lack of double-blinding, lack of the use of placebo and a short follow-up period were the limitations of the present study. Conclusion: Administration of the probiotic Bacillus clausii in addition to conventional treatment does not offer any additional benefit in inducing remission or prevention relapse in AD.