Lactobacillus salivarius plus fructo-oligosaccharide is superior to fructo-oligosaccharide alone for treating children with moderate to severe atopic dermatitis: a double-blind, randomized, clinical trial of efficacy and safety

BACKGROUND: Some probiotics can ameliorate childhood atopic dermatitis (AD). Prebiotics have also shown some efficacy, although when combined with probiotics as synbiotics, their efficacy may improve. OBJECTIVE: We compared the effects of Lactobacillus salivarius and fructo-oligosaccharide (synbiotic) with fructo-oligosaccharide alone (prebiotic) on children with moderate to severe AD. METHODS: We randomly assigned 60 children aged 2-14years with moderate to severe AD [SCORing AD (SCORAD)>25] to a treatment (synbiotic) or a control (prebiotic) group (30 per group). They received one capsule twice daily for 8weeks containing either L. salivarius plus fructo-oligosaccharide (treatment) or fructo-oligosaccharide only (control). SCORAD indices were monitored at weeks 0, 4, 8 and 10 (post-treatment). Laboratory results and AD medication use were also monitored. RESULTS: Baseline demographic and clinical characteristics and SCORAD scores were similar between the two groups. At 8weeks, the treatment group SCORAD scores (27·4±12·7) were significantly lower than for the controls (36·3±14·9) (P=0·022); this difference remained at 10weeks. At 8weeks, treatment group AD intensity was significantly lower (P=0·013); more children had mild AD in the treatment group (52%; 14/27) than the control group (30%; 8/27) (P=0·024). Medication use frequency and eosinophil cationic protein levels were significantly reduced in the treatment group at 8weeks compared with 4 weeks. CONCLUSION: A synbiotic combination of L. salivarius plus fructo-oligosaccharide is superior to the prebiotic alone for treating moderate to severe childhood AD. However, continued follow-up will be necessary to ascertain long-term benefits.