Background: The clinical utility of Bacteroides fragilis in treating autismspectrum disorder (ASD) remains unclear. Therefore, this randomized, doubleblind,placebo-controlled study aimed to explore the therapeutic effects andsafety of B. fragilis BF839 in the treatment of pediatric ASD.
Methods: We examined 60 children aged 2–10 years diagnosed with ASD,and participants received either BF839 powder (10 g/bar with ≥106 CFU/bar ofviable bacteria, two bars/day) or placebo for 16 weeks. The primary outcomeswas Autism Behavior Checklist (ABC) score. The secondary outcomes wereChildhood Autism Rating Scale (CARS), Social Responsiveness Scale (SRS),Normal Development of Social Skills from Infants to Junior High SchoolChildren (S-M), Gastrointestinal Symptom Rating Scale (GSRS) scores, and fecalmicrobiome composition. Assessments were performed on day 0 and at weeks8 and 16.
Results: Compared with the placebo group, the BF839 group showed significantimprovement in the ABC body and object use scores at week 16, which wasmore pronounced in children with ASD aged <4 years. Among children with abaseline CARS score ≥30, the BF839 group showed significant improvementsat week 16 in the ABC total score, ABC body and object use score, CARS score,and GSRS score compared to the placebo group. Only two patients (6.67%)in the BF839 group experienced mild diarrhea. Compared with baseline andplacebo group levels, the BF839 group showed a significant post-interventionincrease in abundance of bifidobacteria and change in the metabolic function ofneuroactive compounds encoded by intestinal microorganisms.
Conclusion: BF839 significantly and safely improved abnormal behavior andgastrointestinal symptoms in children with ASD.
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