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Sleep DisturbancePhase 2NCT04767997

Probiotics on Sleep Among Adults Study

A Phase 2 study testing Probiotic formulation in people with Sleep Disturbance and Sleep Patterns, run by Lallemand Health Solutions at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Disturbance, Sleep Patterns
What is being tested?
Probiotic formulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteCanada
Study dates
12 Oct 2021to 3 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • Use of medication to improve sleep, such as Zopiclone, Doxepine, Trazodone, Melatonin, any H1-antagonist, antipsychotics.
  • Milk and soy allergy.
  • Lactose intolerance.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Québec, G1J 2G2

Other trials in Canada

About this study

Official title: Effects of Probiotics on Sleep Quality Among Mildly Stressed Adults: A Randomized, Placebo-controlled, Double-blind, Parallel Trial

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.

Read the 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.

Being tested
Probiotic formulation, Placebo
Medical subject headings
Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic formulationDietary supplement

    Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.

  • PlaceboDietary supplement

    Participants will be asked to take a placebo capsule daily.

Study groups in NCT04767997
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants in this group will be randomized to receive probiotic formulation for the following 12 weeks.
Receives: Dietary Supplement: Probiotic formulation
Control groupPlacebo comparatorParticipants in this group will be randomized to receive placebo for the following 12 weeks.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms of insomnia

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

    Measured: 12 weeks

Secondary outcomes (12)

  1. Symptoms of insomnia (progressive treatment)

    Comparison of sleep quality assessed by the Insomnia Severity Index among probiotics versus placebo

    Measured: 6 weeks

  2. Objective assessment of sleep: Sleep Latency

    Comparison of sleep latency recorded by actigraphy of probiotic versus placebo

    Measured: 12 weeks

  3. Objective assessment of sleep: Sleep Efficiency

    Comparison of sleep efficiency recorded by actigraphy of probiotic versus placebo

    Measured: 12 weeks

  4. Objective assessment of sleep: Wake after sleep onset (WASO)

    Comparison of WASO recorded by actigraphy of probiotic versus placebo

    Measured: 12 weeks

  5. 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

    Measured: 12 weeks

  6. 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

    Measured: 6 weeks

  7. 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

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 12 weeks

  10. 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.

    Measured: 12 weeks

  11. Levels of sleep-related hormones

    Comparison of the cortisol and melatonin quantified from saliva samples among probiotics versus placebo

    Measured: 12 weeks

  12. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2021
  2. Study start12 Oct 2021
  3. Primary completion3 May 2023
  4. Study completion3 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04767997
Sponsor's protocol ID
L-019
Status last verified
Apr 2024
First submitted
19 Feb 2021
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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).

Publications

  • Binda S, Auclair-Ouellet N, Kassem O, Ivers H, Milev R, Lamy M, Chen S, Oula ML, Morin CM. Effects of probiotic supplementation on sleep and psychological outcomes in adults with mild-to-moderate insomnia symptoms and work-related stress: A randomized, placebo-controlled, double-blind trial. Sleep Med. 2026 Aug 20;148:109223. doi: 10.1016/j.sleep.2026.109223. Online ahead of print.

    PubMed 42628338

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Probiotic formulation in people with Sleep Disturbance and Sleep Patterns, run by Lallemand Health Solutions at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms of insomnia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04767997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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