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Probiotics on Sleep Among Adults Study

Primary Purpose

Sleep Disturbance, Sleep Patterns

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Probiotic formulation
Placebo
Sponsored by
Lallemand Health Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Participants in this group will be randomized to receive probiotic formulation for the following 12 weeks.

Participants in this group will be randomized to receive placebo for the following 12 weeks.

Outcomes

Primary Outcome Measures

Symptoms of insomnia
Comparison of sleep quality assessed by the Insomnia Severity Index among probiotic versus placebo

Secondary Outcome Measures

Symptoms of insomnia (progressive treatment)
Comparison of sleep quality assessed by the Insomnia Severity Index among probiotics versus placebo
Objective assessment of sleep: Sleep Latency
Comparison of sleep latency recorded by actigraphy of probiotic versus placebo
Objective assessment of sleep: Sleep Efficiency
Comparison of sleep efficiency recorded by actigraphy of probiotic versus placebo
Objective assessment of sleep: Wake after sleep onset (WASO)
Comparison of WASO recorded by actigraphy of probiotic versus placebo
Subjective sleep patterns
Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Subjective sleep patterns (progressive treatment)
Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Work-related stress
Comparison of overall score obtained at the Effort-Reward Imbalance (ERI; scores below 0.8 denote higher reward) among probiotics versus placebo
Work Productivity
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.
Change on Quality of life
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.
Mood
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
Comparison of the cortisol and melatonin quantified from saliva samples among probiotics versus placebo
Safety of intervention (number of Serious and Adverse events)
Comparison of the number of adverse events and serious adverse events reported by participants randomized to receive probiotics compared to those receiving placebo.

Full Information

First Posted
February 19, 2021
Last Updated
September 27, 2023
Sponsor
Lallemand Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT04767997
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lallemand Health Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Sleep Patterns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants in this group will be randomized to receive probiotic formulation for the following 12 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in this group will be randomized to receive placebo for the following 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic formulation
Intervention Description
Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants will be asked to take a placebo capsule daily.
Primary Outcome Measure Information:
Title
Symptoms of insomnia
Description
Comparison of sleep quality assessed by the Insomnia Severity Index among probiotic versus placebo
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Symptoms of insomnia (progressive treatment)
Description
Comparison of sleep quality assessed by the Insomnia Severity Index among probiotics versus placebo
Time Frame
6 weeks
Title
Objective assessment of sleep: Sleep Latency
Description
Comparison of sleep latency recorded by actigraphy of probiotic versus placebo
Time Frame
12 weeks
Title
Objective assessment of sleep: Sleep Efficiency
Description
Comparison of sleep efficiency recorded by actigraphy of probiotic versus placebo
Time Frame
12 weeks
Title
Objective assessment of sleep: Wake after sleep onset (WASO)
Description
Comparison of WASO recorded by actigraphy of probiotic versus placebo
Time Frame
12 weeks
Title
Subjective sleep patterns
Description
Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Time Frame
12 weeks
Title
Subjective sleep patterns (progressive treatment)
Description
Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Time Frame
6 weeks
Title
Work-related stress
Description
Comparison of overall score obtained at the Effort-Reward Imbalance (ERI; scores below 0.8 denote higher reward) among probiotics versus placebo
Time Frame
12 weeks
Title
Work Productivity
Description
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.
Time Frame
12 weeks
Title
Change on Quality of life
Description
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.
Time Frame
12 weeks
Title
Mood
Description
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.
Time Frame
12 weeks
Title
Levels of sleep-related hormones
Description
Comparison of the cortisol and melatonin quantified from saliva samples among probiotics versus placebo
Time Frame
12 weeks
Title
Safety of intervention (number of Serious and Adverse events)
Description
Comparison of the number of adverse events and serious adverse events reported by participants randomized to receive probiotics compared to those receiving placebo.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Morin, Ph.D.
Organizational Affiliation
Centre de recherche CERVO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN
City
Quebec
ZIP/Postal Code
G1J 2G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).

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Probiotics on Sleep Among Adults Study

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