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OpenTrials
Active, Not Recruiting

NCT Number: NCT05836168

Effects of Microbiome Modulation on Sleep in Working People

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz

Graz, Austria

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omnibiotic Stress Repair

Dietary Supplement

multispecies probiotic

Other names: Omnibiotic Stress

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Change in subjective sleep quality

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

  1. sleep latency

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  2. sleep duration

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  3. habitual sleep efficiency

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  4. sleep disturbances

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  5. use of sleeping medication

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  6. daytime dysfunction

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  7. Quality of life

    Time frame: 4 weeks

    short form 12 (SF-12)

  8. perceived stress levels

    Time frame: 4 weeks

    measured by perceived stress questionnaire (PSQ-20)

  9. Gastrointestinal quality of life

    Time frame: 4 weeks

    measured by gastrointestinal quality of life index (GIQLI)

Other outcomes

  1. Microbiome composition

    Time frame: 4 weeks

    16s rDNA analysis, beta diversity

  2. Metabolite composition

    Time frame: 4 weeks

    NMR metabolomics

  3. Hair Cortisol levels

    Time frame: 4 weeks

    Hair cortisol

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • CBmed Ges.m.b.H.

Registry information

Official study title

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

Acronym: Sleep

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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