Assessing the effectiveness of a probiotic strain on sleep quality
This study describes how Atlantia designed and conducted a human clinical trial to investigate the outcome of probiotic supplementation in sleep quality and its implications on immunity.
Recent studies have shown that circadian clock misalignment, sleep deprivation, and shift experience may change the circadian clock gene expression and microbial community structure. Given that sleep disturbance/loss is a significant factor that contributes to cognitive impairment, affective disruption, and physical disease; developing effective and safe treatments for disturbed sleep is a vital public priority.
The relationship between probiotics and sleep is still largely misunderstood due to a lack of data from large clinical trials illustrating the beneficial effects of probiotics in improving sleep quality in the general population; similarly, whether immune, metabolic and stress related biomarkers are significantly different in people with poor sleep quality.
The sponsor needed a trusted partner with the capabilities to access the required study population, with enough expertise to design and conduct a gold-standard trial with probiotics to investigate changes in:
• Objective sleep quality, including sleep latency, efficiency, and wake episodes.
• Self-reported physical and mental health, blood biomarkers including inflammatory, hormonal, tryptophan and metabolic markers.
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