Probiotics on Sleep Among Adults Study

Phase 2

Completed

• Conditions: Sleep Disturbance; Sleep Patterns
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic formulation

• Registration Number: NCT04767997
• Lead Sponsor: Lallemand Health Solutions

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.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-24
• Study Start: 2021-10-12
• Primary Completion: 2023-05-03
• Study Completion: 2023-05-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	Participants in this group will be randomized to receive placebo for the following 12 weeks.
Experimental group	Probiotic formulation	Participants in this group will be randomized to receive probiotic formulation for the following 12 weeks.

Primary Outcome Measures

Name	Time	Method
Symptoms of insomnia	12 weeks	Comparison of sleep quality assessed by the Insomnia Severity Index among probiotic versus placebo

Secondary Outcome Measures

Name	Time	Method
Subjective sleep patterns	12 weeks	Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Objective assessment of sleep: Wake after sleep onset (WASO)	12 weeks	Comparison of WASO recorded by actigraphy of probiotic versus placebo
Work Productivity	12 weeks	Comparison of overall score obtained at the Work Productivity and Activity Impairment (WPAI; 0% to 100%, with higher scores indicating higher impairment and lower productivity) questionnaire among probiotics versus placebo groups.
Mood	12 weeks	Comparison of overall score obtained at the HADS questionnaire (0 - no mood disorder to 21 - responder likely suffers depression and/or anxiety) among probiotics versus placebo groups.
Levels of sleep-related hormones	12 weeks	Comparison of the cortisol and melatonin quantified from saliva samples among probiotics versus placebo
Objective assessment of sleep: Sleep Latency	12 weeks	Comparison of sleep latency recorded by actigraphy of probiotic versus placebo
Work-related stress	12 weeks	Comparison of overall score obtained at the Effort-Reward Imbalance (ERI; scores below 0.8 denote higher reward) among probiotics versus placebo
Symptoms of insomnia (progressive treatment)	6 weeks	Comparison of sleep quality assessed by the Insomnia Severity Index among probiotics versus placebo
Objective assessment of sleep: Sleep Efficiency	12 weeks	Comparison of sleep efficiency recorded by actigraphy of probiotic versus placebo
Change on Quality of life	12 weeks	Comparison of overall score obtained at the questionnaires WHOQOL-Bref (0 to 100; higher scores denote higher quality of life) and Kessler 10 (K10; 5 - no psychological distress to 50 - high psychological distress) among probiotics versus placebo groups.
Subjective sleep patterns (progressive treatment)	6 weeks	Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Safety of intervention (number of Serious and Adverse events)	12 weeks	Comparison of the number of adverse events and serious adverse events reported by participants randomized to receive probiotics compared to those receiving placebo.

Trial Locations

Locations (1)

Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN; 🇨🇦 Quebec, Canada