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

The impact of psychobiotics on ASD is unclear. 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). 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. The results support that PS128 has beneficial effects on behavioral and emotional problems in young children with ASD.