Clinical trial NCT04767997: Probiotics on Sleep Among Adults Study
Official title: Effects of Probiotics on Sleep Quality Among Mildly Stressed Adults: A Randomized, Placebo-controlled, Double-blind, Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disturbance
Sleep Patterns
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Men and women aged between 18 and 65 years-old
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:

1. Presence of unrelated sleep disorders (Obstructive Sleep Apnea and REM Sleep Behavior Disorder) as per questionnaires (STOP BANG and the RBD single question, respectively).
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.

Primary outcomes:
measure: Symptoms of insomnia
timeFrame: 12 weeks
Secondary outcomes:
measure: Symptoms of insomnia (progressive treatment)
timeFrame: 6 weeks
measure: Objective assessment of sleep: Sleep Latency
timeFrame: 12 weeks
measure: Objective assessment of sleep: Sleep Efficiency
timeFrame: 12 weeks
measure: Objective assessment of sleep: Wake after sleep onset (WASO)
timeFrame: 12 weeks
measure: Subjective sleep patterns
timeFrame: 12 weeks
measure: Subjective sleep patterns (progressive treatment)
timeFrame: 6 weeks
measure: Work-related stress
timeFrame: 12 weeks
measure: Work Productivity
timeFrame: 12 weeks
measure: Change on Quality of life
timeFrame: 12 weeks
measure: Mood
timeFrame: 12 weeks
measure: Levels of sleep-related hormones
timeFrame: 12 weeks
measure: Safety of intervention (number of Serious and Adverse events)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN
Study officials:
affiliation: Centre de recherche CERVO
name: Charles Morin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: