A novel synbiotic (SCM06) for anxiety and sensory hyperresponsiveness in children with autism spectrum disorder: an open-label pilot study.

SCM06 synbiotic was safe and well-tolerated in children with ASD over 12 weeks.

• Open-label pilot study with 30 children with ASD (mean age 8.2 years, 22 males).
• Treatment duration was 12 weeks.
• No significant safety concerns were reported.
• Compliance was assessed as part of the study outcomes.

Significant improvements were observed in anxiety, sensory hyperresponsiveness, and abdominal pain following SCM06 treatment.

• Study population was 30 children with ASD.
• Anxiety, sensory hyperresponsiveness, and abdominal pain were primary symptom outcomes assessed.
• Improvements were observed across all three symptom domains.
• The study was an open-label design without a control group, limiting causal inference.

Increase in Bifidobacterium pseudocatenulatum following SCM06 treatment was associated with improved functional abdominal pain.

• Association between increased B. pseudocatenulatum and improved functional abdominal pain was statistically significant (p = 0.0011, p_adj = 0.054).
• Stool samples were collected for metagenomic analysis over 12 weeks.
• This association suggests a potential mechanistic link between gut microbiota changes and gastrointestinal symptom improvement.

Abundances of valeric acid and butyric acid increased following SCM06 treatment.

• Valeric acid increase was statistically significant at p_adj = 0.004.
• Butyric acid increase showed p_adj = 0.072.
• Metabolomic analysis of stool samples was conducted over 12 weeks.
• Both are short-chain fatty acids potentially relevant to gut-brain axis signaling.

Coprococcus comes and Veillonella dispar were identified as candidate microbial mediators of symptom improvements.

• These species were identified through metagenomic analysis of stool samples collected over 12 weeks.
• Both species were described as 'key microbial species' and 'candidate mediators of symptom improvements.'
• The mediating role of these species was identified in an open-label study context and requires further confirmation.

Anxiety and sensory hyperresponsiveness are common in children with ASD but effective treatments are lacking, and targeting the microbiota-gut-brain axis is a promising strategy.

• The study was motivated by the lack of effective treatments for anxiety and sensory hyperresponsiveness in ASD.
• SCM06 was specifically designed to target anxiety and sensory hyperresponsiveness via the gut-brain axis.
• The authors call for further randomised controlled trials to confirm clinical efficacy.