Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2021-10-12
2023-05-03
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group
Participants in this group will be randomized to receive probiotic formulation for the following 12 weeks.
Probiotic formulation
Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.
Control group
Participants in this group will be randomized to receive placebo for the following 12 weeks.
Placebo
Participants will be asked to take a placebo capsule daily.
Interventions
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Probiotic formulation
Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.
Placebo
Participants will be asked to take a placebo capsule daily.
Eligibility Criteria
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Inclusion Criteria
2. Scores 8 ≥ in the ISI
3. Having a score higher to 0.8 in the ERI questionnaire
4. Body mass index (BMI) below or equal to 30.
5. Otherwise healthy
6. Working (paid or unpaid) at the same position for at least the past 3 months and plans to have the same position for the duration of the study.
7. Willing to discontinue consumption of probiotics supplements and probiotic fortified products throughout the study
Exclusion Criteria
2. Diagnosis of mental disorders (diagnosed by a health professional in the last year, including insomnia) or showing high psychosocial stress assessed by K10 (score equal or above 17).
3. Diabetes (type I and II), blood/bleeding disorders, liver and/or kidney disorders, unstable cardiovascular diseases, neurological diseases (such as, but not limited to Alzheimer's disease, Parkinson's disease, epilepsy), gastrointestinal diseases (such as, but not limited to gastric ulcers, Crohn's disease, ulcerative colitis).
4. Irregular bedtime schedule (schedule resulting in usual bedtime earlier than 8 PM or later than 2 AM or arising time earlier than 4 AM or later than 10 AM).
5. Currently suffering from periodontitis.
6. Pregnancy, planning to be pregnant or currently breastfeeding.
7. Use of medication to improve sleep, such as Zopiclone, Doxepine, Trazodone, Melatonin, any H1-antagonist, antipsychotics.
8. Milk and soy allergy.
9. Lactose intolerance.
18 Years
65 Years
ALL
Yes
Sponsors
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Lallemand Health Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Morin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Centre de recherche CERVO
Locations
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Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN
Québec, , Canada
Countries
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Other Identifiers
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L-019
Identifier Type: -
Identifier Source: org_study_id
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