NCT05836168

Effects of Microbiome Modulation on Sleep in Working People

Effects of Microbiome Modulation on Sleep in Working People: A Randomized Controlled Pilot Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

We aim to test whether quality of sleep in working people can be improved by modulating the gut microbiome with probiotics.

Detailed description

A good night´s sleep is essential for our attention, cognition and mood. Sleep fragmentation can therefore lead to poor performance, loss of productivity, and errors, incidents and accidents in the workplace. Sleep disruption has further been associated with metabolic and cardiovascular diseases, psychiatric diseases and cancer.The gut microbiome and its metabolites exhibit diurnal rhythmicity in response to food intake and influence human clock gene expression and sleep duration. Sleep fragmentation causes dysbiosis and hormonal disturbances. First data from animal experiments and small human studies imply that modulation of the gut microbiome may improve sleep quality and thereby mental and physical health. Probiotics can alter the gut microbiota composition and can mitigate positive effects on psychiatric symptoms via the microbiome gut-brain axis by metabolites such as short-chain fatty acids (SCFA) that can pass the blood-brain barrier and thereby comprise a potential strategy to improve sleep quality and other quality of life related outcomes. Evidence on the effect of probiotics to improve quality of sleep is available from several small-scale clinical studies in different populations. The benefit seems to be stronger in people under physical or mental stress. Also, a large marketing survey conducted in Germany in over \>10.000 consumers indicated that a multispecies probiotic, that has been described to improve inflammation, gut barrier dysfunction and immune function in different patient cohorts is able to improve sleep quality and quality of life, however since this study was non-randomized, a bias cannot be excluded. Understanding the interaction between the gut microbiome, chronobiology and health is therefore of high importance and in line with the United Nations' Sustainable Development Goal 3 of the 2030 Agenda for Sustainable Development to "ensure healthy lives and promoting well-being for all at all ages".

Conditions

• Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omnibiotic Stress Repair	multispecies probiotic
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2023-05-31
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2023-05-01
• Last updated: 2025-02-17

Locations

1 site across 1 country: Austria