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<p>Gut microbiota dysbiosis has been implicated in the pathophysiology of autism spectrum disorder (ASD). This study aimed to evaluate the effects of <i>Limosilactobacillus reuteri</i> LR-99 on gut microbiota composition and core symptoms in children with ASD. In this single-arm pilot study, 17 children with ASD received <i>L. reuteri</i> LR-99 (5.0 × 10¹⁰ CFU, three times daily) for four weeks. Gut microbiota profiles were characterized using metagenomic sequencing and compared with those of neurotypical family members. Behavioral symptoms were assessed using the Childhood Autism Rating Scale (CARS) and Social Responsiveness Scale (SRS). Gastrointestinal symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) and Bristol Stool Form Scale (BSFS). The intervention significantly modulated the gut microbiota, characterized by an increased relative abundance of <i>Bifidobacterium</i> and a decreased relative abundance of <i>Proteobacteria</i>. Clinically, the intervention was associated with significant improvements in gastrointestinal symptoms (lower GSRS scores and more normal stool consistency on the BSFS) and in core autistic behaviors (lower CARS and SRS scores). The gut microbiota profile of children with ASD also shifted toward that of neurotypical controls. A four-week <i>L. reuteri</i> LR-99 intervention was associated with beneficial modulation of the gut microbiota, alleviation of gastrointestinal symptoms, and improvement in behavioral symptoms in children with ASD. These preliminary findings suggest that <i>L. reuteri</i> LR-99 may be a promising adjunctive therapy; however, given the limitations of the single-arm design and age differences between groups, larger randomized, placebo-controlled trials are needed to confirm efficacy.</p>

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Limosilactobacillus reuteri LR-99 Modulates Gut Microbiota and Core Symptoms in Children with Autism Spectrum Disorder: A Single-arm Pilot Study

  • 期刊论文

  • 发表日期：

    2026年3月24日

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  • Kai Gong,
  • Ziying Xie,
  • Ping Zhang,
  • Jing Xu,
  • Jiangfeng Huang,
  • Xingyu Li,
  • Lihong Huang

摘要

Gut microbiota dysbiosis has been implicated in the pathophysiology of autism spectrum disorder (ASD). This study aimed to evaluate the effects of Limosilactobacillus reuteri LR-99 on gut microbiota composition and core symptoms in children with ASD. In this single-arm pilot study, 17 children with ASD received L. reuteri LR-99 (5.0 × 10¹⁰ CFU, three times daily) for four weeks. Gut microbiota profiles were characterized using metagenomic sequencing and compared with those of neurotypical family members. Behavioral symptoms were assessed using the Childhood Autism Rating Scale (CARS) and Social Responsiveness Scale (SRS). Gastrointestinal symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) and Bristol Stool Form Scale (BSFS). The intervention significantly modulated the gut microbiota, characterized by an increased relative abundance of Bifidobacterium and a decreased relative abundance of Proteobacteria. Clinically, the intervention was associated with significant improvements in gastrointestinal symptoms (lower GSRS scores and more normal stool consistency on the BSFS) and in core autistic behaviors (lower CARS and SRS scores). The gut microbiota profile of children with ASD also shifted toward that of neurotypical controls. A four-week L. reuteri LR-99 intervention was associated with beneficial modulation of the gut microbiota, alleviation of gastrointestinal symptoms, and improvement in behavioral symptoms in children with ASD. These preliminary findings suggest that L. reuteri LR-99 may be a promising adjunctive therapy; however, given the limitations of the single-arm design and age differences between groups, larger randomized, placebo-controlled trials are needed to confirm efficacy.