SleepSleepNCT05836168
Effects of Microbiome Modulation on Sleep in Working People
A study testing Omnibiotic Stress Repair in people with Sleep, run by Medical University of Graz at 1 site in Austria.
Trial summary
We aim to test whether quality of sleep in working people can be improved by modulating the gut microbiome with probiotics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Omnibiotic Stress Repair
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteAustria
- Study dates
- 31 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Omnibiotic Stress Repair, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnibiotic Stress RepairDietary supplement
Also called Omnibiotic Stress
multispecies probiotic
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | 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. Receives: Dietary Supplement: Omnibiotic Stress Repair |
| Placebo | Placebo comparator | 2 x 3g of a similar looking and tasting placebo per day for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
Secondary outcomes (9)
sleep latency
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
sleep duration
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
habitual sleep efficiency
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
sleep disturbances
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
use of sleeping medication
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
daytime dysfunction
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
Quality of life
short form 12 (SF-12)
Measured: 4 weeks
perceived stress levels
measured by perceived stress questionnaire (PSQ-20)
Measured: 4 weeks
Gastrointestinal quality of life
measured by gastrointestinal quality of life index (GIQLI)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start31 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- CBmed Ges.m.b.H.
- Responsible party
- Principal investigator, Vanessa Stadlbauer-Koellner, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836168
- Sponsor's protocol ID
- 35-176 ex 22/23
- Acronym
- Sleep
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microbiome Modulation on Sleep in Working People: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05836168
- Acronym / sponsor ID
- Sleep / 35-176 ex 22/23
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- CBmed Ges.m.b.H.
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Omnibiotic Stress Repairmulti-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 comparator | Dietary Supplement: Placebo2 x 3g of a similar looking and tasting placebo per day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnibiotic Stress RepairAlso: Omnibiotic Stressmultispecies probiotic | Dietary supplement | Probiotic |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Change in subjective sleep quality
Time frame: 4 weeks
Pittsburgh Sleep Quality Index (PSQI)
9 secondary outcomes
sleep latency
Time frame: 4 weeks
sleep duration
Time frame: 4 weeks
habitual sleep efficiency
Time frame: 4 weeks
sleep disturbances
Time frame: 4 weeks
use of sleeping medication
Time frame: 4 weeks
daytime dysfunction
Time frame: 4 weeks
Quality of life
Time frame: 4 weeks
perceived stress levels
Time frame: 4 weeks
Gastrointestinal quality of life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnibiotic Stress Repair in people with Sleep, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective sleep quality (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.