Effects of Microbiome Modulation on Sleep in Working People (Sleep)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Omnibiotic Stress Repair

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic; 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.	Dietary supplement: Omnibiotic Stress Repair; multispecies probiotic; Other Names: Omnibiotic Stress
Placebo Comparator: Placebo; 2 x 3g of a similar looking and tasting placebo per day for 4 weeks.	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective sleep quality	Pittsburgh Sleep Quality Index (PSQI)	4 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome composition	16s rDNA analysis, beta diversity	4 weeks
Metabolite composition	NMR metabolomics	4 weeks
Hair Cortisol levels	Hair cortisol	4 weeks

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: CBmed Ges.m.b.H.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 35-176 ex 22/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on the results, according to the grant contract, IPR will be shared among partners and after these discussions IPD may be shared. Microbiome sequencing data will be deposited in a public repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No