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Effects of Probiotics on Sleep Quality Among Mildly Stressed Adults: A Randomized, Placebo-controlled, Double-blind, Parallel Trial
The aim of this study is to determine the impact of a probiotic formulation on subjective sleep patterns. It is hypothesized that participants given the probiotics will improve their sleep patterns compared to participants receiving placebo.
Participants with symptoms of insomnia and work-related stress will be recruited to participate in a randomized, placebo-controlled, double-blind interventional study for approximately 15 since the signature of the informed consent. Participants will first be seen at the Screening visit when they will be administered several questionnaires to determine eligibility (assessing symptoms of insomnia, work-related stress, psychological distress and other sleep disorders). Participants will receive a 2-week sleep journal and an actigraphy to record their sleep patterns. At visit 2 returning participants will be randomized to receive probiotics or placebo for the following 12 weeks. During this visit, participants will be administered questionnaires assessing sleep quality, work-related productivity, quality of life, and mood. Participants will also be asked to bring to site a stool sample and saliva samples. Participants will be asked to return at 6 weeks for visit 3. During this visit participants will be administered questionnaires (insomnia, sleep quality, work-related stress and productivity, quality of life, mood and psychological distress). They will also bring two saliva samples. Two weeks prior to visit 4, participants will be asked to complete another sleep journal and be dispensed another actigraphy which shall be returned at visit 4. Lastly, participants will return on for visit 4 at week 12 in which the same questionnaires as visit 3 will be administered. Participants will also be asked to bring to site another stool sample and two saliva samples.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN
Québec, Canada
Start Date
October 12, 2021
Primary Completion Date
May 3, 2023
Completion Date
May 3, 2023
Last Updated
April 3, 2024
70
ACTUAL participants
Probiotic formulation
DIETARY_SUPPLEMENT
Placebo
DIETARY_SUPPLEMENT
Lead Sponsor
Lallemand Health Solutions
NCT07354776
NCT07119268
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07179172