Effects of Microbiome Modulation on Sleep in Working People

NCT05836168 | Active Not Recruiting

• 1 other identifier: 35-176 ex 22/23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Change in subjective sleep quality

  Pittsburgh Sleep Quality Index (PSQI)

  4 weeks

Secondary Outcomes (9)

• sleep latency

  4 weeks

• sleep duration

  4 weeks

• habitual sleep efficiency

  4 weeks

• sleep disturbances

  4 weeks

• use of sleeping medication

  4 weeks

Other Outcomes (3)

• Microbiome composition

  4 weeks

• Metabolite composition

  4 weeks

• Hair Cortisol levels

  4 weeks

Study Arms (2)

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.

Dietary Supplement: Omnibiotic Stress Repair

Placebo

PLACEBO COMPARATOR

2 x 3g of a similar looking and tasting placebo per day for 4 weeks.

Dietary Supplement: Placebo

Interventions

Omnibiotic Stress Repair DIETARY_SUPPLEMENT

multispecies probiotic

Also known as: Omnibiotic Stress

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• CBmed Ges.m.b.H.: collaborator

Study Sites (1)

Medical University Graz

Graz, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo, outcome assessors are blinded to the group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. PD Dr. med

Model Details: Randomized, placebo controlled study

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: May 31, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

AU (1)