Evaluation of efficacy and safety of Lactobacillus rhamnosus in children aged 4–48 months with atopic dermatitis: An 8-week, double-blind, randomized, placebo-controlled study

Abstract

Objective: The main objective of this study was to evaluate the efficacy and safety of Lactobacillus rhamnosus in children aged 4–48 months with atopic dermatitis. Methods: The design of this study was a two-center, double-blind, randomized, and placebo-controlled study with two parallel groups to evaluate the efficacy and safety profile of L. rhamnosus in children aged 4–48 months with atopic dermatitis diagnosed using Hanifin and Rajka criteria and with a Scoring of Atopic Dermatitis (SCORAD) ≥ 15 at enrollment. The duration of this study was 8 weeks with a total of five visits. The enrolled patients were allocated into either a treatment group (one ComProbi capsule containing L. rhamnosus a day) or a control group (one capsule of placebo a day) at a ratio of 1:1. The primary endpoint was to compare the mean change from baseline in SCORAD after 8 weeks of treatment. The other secondary end points were to compare the following: the mean changes from baseline in SCORAD at postbaseline visits, the frequency and total amount of the use of corticosteroids during the 8-week treatment, the frequency of atopic dermatitis and the symptom-free duration, the mean changes from baseline in Infant Dermatitis Quality of Life Questionnaire at Week 4 and Week 8, and the mean changes from baseline in the Dermatitis Family Impact Questionnaire at Week 4 and Week 8. Results: The mean changes in SCORAD from baseline at Week 8 was −21.69 ± 16.56 in the L. rhamnosus group and −12.35 ± 12.82 in the placebo group for the intent-to-treat population (p = 0.014). For the per-protocol population, the mean change of SCORAD from baseline was −23.20 ± 15.24 in the L. rhamnosus group and −12.35 ± 12.82 in the placebo group (p = 0.003). Significant differences were demonstrated between groups at Week 8 in intensity in the intent-to-treat population and per-protocol population. Throughout the period, the amount of topical corticosteroids used showed no difference between groups. No significant difference was noted in the overall symptom-free durations compared with the placebo group. Infant Dermatitis Quality of Life Questionnaires and Dermatitis Family Impact Questionnaires scores improved significantly at Week 4 and Week 8 but did not reach statistical significance. Adverse events were documented in 14/33 patients in the L. rhamnosus group (42.42%, 35 events) and in 15/33 placebo patients (45.45%, 37 events). Conclusions: The results of this study indicated that L. rhamnosus was effective in decreasing symptoms of atopic dermatitis after an 8-week treatment by comparing the mean change of SCORAD from baseline with a placebo (p < 0.05). The reduction in SCORAD resulted from a consistent decrease in all components of SCORAD. Patients who took L. rhamnosus for 8 weeks expressed less SCORAD in the three components: area of affected skin, intensity of atopic dermatitis, and patient symptoms, with a significant decrease in the mean change of intensity from baseline compared with placebo.

Keywords

• atopic dermatitis
• efficacy
• Lactobacillus rhamnosus