Effects of Microbiome Modulation on Sleep in Working People

Sleep Clinical Trial

— Sleep  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836168
• Other study ID #: 35-176 ex 22/23
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: May 2025

Study information

• Verified date: June 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Omnibiotic Stress Repair
multispecies probiotic
• Placebo
Placebo

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	CBmed Ges.m.b.H.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiome composition	16s rDNA analysis, beta diversity	4 weeks
Other	Metabolite composition	NMR metabolomics	4 weeks
Other	Hair Cortisol levels	Hair cortisol	4 weeks
Primary	Change in subjective sleep quality	Pittsburgh Sleep Quality Index (PSQI)	4 weeks
Secondary	sleep latency	Pittsburgh Sleep Quality Index (PSQI)	4 weeks
Secondary	sleep duration	Pittsburgh Sleep Quality Index (PSQI)	4 weeks
Secondary	habitual sleep efficiency	Pittsburgh Sleep Quality Index (PSQI)	4 weeks
Secondary	sleep disturbances	Pittsburgh Sleep Quality Index (PSQI)	4 weeks
Secondary	use of sleeping medication	Pittsburgh Sleep Quality Index (PSQI)	4 weeks
Secondary	daytime dysfunction	Pittsburgh Sleep Quality Index (PSQI)	4 weeks
Secondary	Quality of life	short form 12 (SF-12)	4 weeks
Secondary	perceived stress levels	measured by perceived stress questionnaire (PSQ-20)	4 weeks
Secondary	Gastrointestinal quality of life	measured by gastrointestinal quality of life index (GIQLI)	4 weeks