Safety and Tolerability of the Gut Bacterium Phascolarctobacterium faecium DSM 32890.

Administration of P. faecium DSM 32890 to Wistar rats for 28 days caused no behavioral, physiological, histologic, immune, or biochemical alterations.

• A repeated-dose oral toxicity study of 28 days was performed in male and female Wistar rats.
• Adverse signs and clinical outcomes were assessed along with histological, hematologic, biochemical, and immune markers.
• No treatment-related adverse effects were identified across any of the measured parameters.

In a pilot human intervention trial, P. faecium DSM 32890 showed no evidence of adverse effects on general health, hematological and biochemical profiles, bowel habits, or gastrointestinal symptoms.

• The trial included 20 participants: 11 overweight and 9 normal weight individuals.
• Participants received P. faecium DSM 32890 daily for 15 days.
• Body composition, dietary intake, physical activity, clinical data, perceived health, gastrointestinal symptoms, and blood analyses were assessed.
• No safety concerns were identified in any participant group.

Overweight participants experienced reductions in flatulence and nausea after the intervention with P. faecium DSM 32890.

• This improvement in gastrointestinal symptoms was observed specifically in the overweight subgroup (n=11).
• Normal weight participants (n=9) were also assessed but this specific benefit was noted in the overweight group.
• The finding suggests potential tolerability benefits in individuals with overweight.

The prevalence of the commensal gut bacterium species P. faecium has been associated with normal weight in humans.

• P. faecium is described as a commensal gut bacterium species.
• Preclinical evidence suggests the strain P. faecium DSM 32890 exerts beneficial effects on metabolic and immune function in diet-induced obesity.
• These associations motivated the safety and tolerability evaluation reported in this study.