Adjunctive psychobiotic Lactiplantibacillus plantarum PS128 ameliorates gastrointestinal comorbidities and alters circulating miRNAs and gut microbiota in children with Tourette syndrome: a randomized controlled trial.

The primary endpoint of reduction in YGTSS score did not differ significantly between the PS128 and placebo groups.

• This was a double-blind, randomized, placebo-controlled trial in children aged 4-18 years with Tourette syndrome.
• 73 participants completed the 12-week study.
• The Yale Global Tic Severity Scale (YGTSS) was used to assess tic severity.
• Improvements in YGTSS, CGI, and neuropsychological outcomes were described as 'comparable between groups.'

The PS128 group exhibited significantly greater reductions in gastrointestinal symptoms, particularly upper abdominal pain, compared to placebo.

• Gastrointestinal discomfort was assessed using the Visual Analogue Scale of Gastrointestinal Discomfort (VAS-GI).
• The intervention lasted 12 weeks.
• Upper abdominal pain was specifically identified as the gastrointestinal symptom showing the most notable improvement.
• No intervention-related adverse events were reported.

The PS128 group showed a trend toward improved attentional performance on the Continuous Performance Test (CPT).

• Attentional performance was assessed using the Continuous Performance Test (CPT).
• The improvement was described as a 'trend' rather than a statistically significant difference.
• Neuropsychological assessments were also conducted alongside the CPT.
• The 12-week intervention period was used for all clinical assessments.

miRNA sequencing identified eight differentially expressed miRNAs following PS128 intervention, predicted to be involved in nervous system development and synaptic regulation.

• Blood-based miRNA profiling was conducted to explore potential mechanisms.
• Eight miRNAs were identified as differentially expressed in the PS128 group.
• These miRNAs were predicted to be involved in 'nervous system development and synaptic regulation.'
• qRT-PCR validation confirmed significant upregulation of miR-199a-3p and miR-143-3p in the PS128 group compared with placebo.

Fecal microbiota analysis revealed increased Lactiplantibacillus abundance after PS128 intervention, which positively correlated with miR-199a-3p expression and negatively correlated with CGI scores.

• Fecal microbiota analyses were conducted to explore gut-brain axis mechanisms.
• Increased abundance of Lactiplantibacillus was observed following the PS128 intervention.
• Lactiplantibacillus abundance positively correlated with miR-199a-3p expression.
• Lactiplantibacillus abundance negatively correlated with Clinical Global Impression (CGI) scores, suggesting an association with overall clinical improvement.
• These findings were interpreted as supporting gut-brain axis molecular changes.

PS128 is a psychobiotic strain of Lactiplantibacillus plantarum described as known to influence brain function through neurotransmitter modulation.

• PS128 was administered as an adjunctive therapy alongside standard care for TS.
• The strain is described as 'well-studied' in its effects on the gut-brain axis.
• The intervention duration was 12 weeks.
• The study was conducted in a pediatric population aged 4-18 years.

No intervention-related adverse events were reported in either the PS128 or placebo group during the 12-week trial.

• 73 participants completed the study.
• The trial was conducted in children aged 4-18 years with Tourette syndrome.
• Safety was monitored throughout the 12-week intervention period.
• The absence of adverse events supports the tolerability of PS128 as an adjunctive therapy.