NCT04767997

Probiotics on Sleep Among Adults Study

Effects of Probiotics on Sleep Quality Among Mildly Stressed Adults: A Randomized, Placebo-controlled, Double-blind, Parallel Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Disturbance
• Sleep Patterns

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic formulation	Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.
DIETARY_SUPPLEMENT	Placebo	Participants will be asked to take a placebo capsule daily.

Timeline

• Start date: 2021-10-12
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2021-02-24
• Last updated: 2024-04-03

Locations

1 site across 1 country: Canada