Probiotic intervention in young children with autism spectrum disorder in Taiwan: A randomized, double-blinded, placebo-controlled trial

Background: The impact of psychobiotics on ASD is unclear.Method: In this double-blinded, randomized, placebo-controlled trial, 86 children (aged 2.5-7 years) with ASD were recruited and assigned randomly to either the probiotic or placebo group to explore the effects of the probiotic Lactobacillus plantarum PS128 (PS128). During the first 2 months of the study, the children received either the probiotic or placebo. After that, all of the children received PS128 for 2 more months. We categorized individuals who took PS128 for the entire 4-month duration as the "PS128 early use group" (E group), while those who initially received the placebo for 2 months and then took PS128 for the subsequent 2 months were classified as the "PS128 late use group" (L group).Results: After adjusting for possible confounders, the results showed that the anxious/depressed subscale score of the Achenbach System of Empirically Based Assessment significantly improved in the E group after the first 2-month intervention (P = 0.044) when compared to the L group. In the subsequent 2 months, the L group showed a significant improvement in this subscale (P = 0.017). While the improvement observed during the first two months was not sustained on average in the E group from V2 to V3, this variability can be attributed to the influence of an outlier. Upon analyzing the hyperactivity subscale of the Attention-Deficit/Hyperactivity Disorder Test, no significant differences were found across multiple time points.Conclusions: The results support that PS128 has beneficial effects on behavioral and emotional problems in young children with ASD.