Clinical trial NCT05836168: Effects of Microbiome Modulation on Sleep in Working People
Official title: Effects of Microbiome Modulation on Sleep in Working People: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: CBmed Ges.m.b.H.
First posted: 2023-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled study
Primary purpose: SUPPORTIVE_CARE

Brief 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".

Eligibility criteria: Inclusion criteria

* Age \>18
* Working
* Signed Informed Consent;
* Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years
* Pittsburgh Sleep Quality index score of \>5 Exclusion criteria
* Diagnosed with a gastrointestinal infection within 4 weeks prior to screening
* Severe gastrointestinal diseases (e.g. inflammatory bowel diseases)
* Received any of the following products/medication within 4 weeks prior to screening: systemic antibiotics, prokinetics, prebiotic supplements, probiotic supplements
* Concomitant diseases or other circumstances that suggest that the patients are not eligible for participation in the study

Primary outcomes:
measure: Change in subjective sleep quality
timeFrame: 4 weeks
Secondary outcomes:
measure: sleep latency
timeFrame: 4 weeks
measure: sleep duration
timeFrame: 4 weeks
measure: habitual sleep efficiency
timeFrame: 4 weeks
measure: sleep disturbances
timeFrame: 4 weeks
measure: use of sleeping medication
timeFrame: 4 weeks
measure: daytime dysfunction
timeFrame: 4 weeks
measure: Quality of life
timeFrame: 4 weeks
measure: perceived stress levels
timeFrame: 4 weeks
measure: Gastrointestinal quality of life
timeFrame: 4 weeks
Other outcomes:
measure: Microbiome composition
timeFrame: 4 weeks
measure: Metabolite composition
timeFrame: 4 weeks
measure: Hair Cortisol levels
timeFrame: 4 weeks
Locations:
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
References: