Status:
COMPLETED
Probiotics on Sleep Among Adults Study
Lead Sponsor:
Lallemand Health Solutions
Conditions:
Sleep Disturbance
Sleep Patterns
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 co...
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 si...
Eligibility Criteria
Inclusion
- Men and women aged between 18 and 65 years-old
- Scores 8 ≥ in the ISI
- Having a score higher to 0.8 in the ERI questionnaire
- Body mass index (BMI) below or equal to 30.
- Otherwise healthy
- 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.
- Willing to discontinue consumption of probiotics supplements and probiotic fortified products throughout the study
Exclusion
- Presence of unrelated sleep disorders (Obstructive Sleep Apnea and REM Sleep Behavior Disorder) as per questionnaires (STOP BANG and the RBD single question, respectively).
- 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).
- 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).
- 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).
- Currently suffering from periodontitis.
- Pregnancy, planning to be pregnant or currently breastfeeding.
- Use of medication to improve sleep, such as Zopiclone, Doxepine, Trazodone, Melatonin, any H1-antagonist, antipsychotics.
- Milk and soy allergy.
- Lactose intolerance.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04767997
Start Date
October 12 2021
End Date
May 3 2023
Last Update
April 3 2024
Active Locations (1)
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1
Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN
Québec, Canada, G1J 2G2