Effects of Microbiome Modulation on Sleep in Working People

Not Applicable

Active, not recruiting

• Conditions: Sleep
• Interventions: Dietary Supplement: Omnibiotic Stress Repair; Dietary Supplement: Placebo

• Registration Number: NCT05836168
• Lead Sponsor: Medical University of Graz

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".

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-05-01
• Study Start: 2023-05-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Omnibiotic Stress Repair	multi-strain probiotic mixture containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19 in a matrix of maize starch, maltodextrin, inulin, potassium chloride, rice protein, magnesium sulfate, fructooligosaccharides, amylases and mangane sulfate at a dose of 2 x 3g per day for 4 weeks.
Placebo	Placebo	2 x 3g of a similar looking and tasting placebo per day for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in subjective sleep quality	4 weeks	Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Name	Time	Method
sleep duration	4 weeks	Pittsburgh Sleep Quality Index (PSQI)
habitual sleep efficiency	4 weeks	Pittsburgh Sleep Quality Index (PSQI)
sleep latency	4 weeks	Pittsburgh Sleep Quality Index (PSQI)
sleep disturbances	4 weeks	Pittsburgh Sleep Quality Index (PSQI)
use of sleeping medication	4 weeks	Pittsburgh Sleep Quality Index (PSQI)
daytime dysfunction	4 weeks	Pittsburgh Sleep Quality Index (PSQI)
Gastrointestinal quality of life	4 weeks	measured by gastrointestinal quality of life index (GIQLI)
perceived stress levels	4 weeks	measured by perceived stress questionnaire (PSQ-20)
Quality of life	4 weeks	short form 12 (SF-12)

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Austria