Sleep QualityNCT07498712
Effect of L. Reuteri LM1063 on Sleep Health Improvement
A study testing Limosilactobacillus reuteri LM1063 in people with Sleep Quality and Sleep Wake Disorders, run by Lactomason Co., Ltd. at 1 site in South Korea.
Trial summary
Purpose: The purpose of this clinical trial is to evaluate the efficacy and safety of Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults. Based on the microbiota-gut-brain axis, this study aims to scientifically analyze whether the supplementation of this specific probiotic strain can… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Sleep Wake Disorders
- What is being tested?
- Limosilactobacillus reuteri LM1063
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female adults aged 19 to 65.
- Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher.
- Voluntarily agreed to participate and signed the informed consent form.
Who cannot join
- Severe sleep disorders (Insomnia Severity Index ≥ 22 or ≤ 7).
- Medical conditions causing sleep disorders (Sleep apnea, Restless legs syndrome, Depression, Narcolepsy, etc.).
- Intake of medications affecting sleep within 1 month before the first visit.
- Intake of probiotics or fermented milk products within 1 month before the first visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
P&K Skin Research Center
Seoul, Yeongdeungpo, 07236
Hyun-ju Kim, 82-70-4850-6440, hj.kim9@pnkskin.com
About this study
Official title: Effect and Safety of Limosilactobacillus Reuteri LM1063 Supplementation on the Improvement of Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Purpose:
The purpose of this clinical trial is to evaluate the efficacy and safety of Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults. Based on the microbiota-gut-brain axis, this study aims to scientifically analyze whether the supplementation of this specific probiotic strain can enhance sleep quality.
Read more
Methodology:
This is a randomized, double-blind, placebo-controlled, single-center clinical trial. A total of 80 participants (40 in the test group and 40 in the control group) will be enrolled. Participants in the test group will consume 500 mg of L. reuteri LM1063 (1.0 x 10^10 CFU/day) once daily for 8 weeks, while the control group will receive a placebo.
Key Evaluations:
To assess sleep improvement, various parameters will be measured before and after the 8-week intake period:
- Primary Outcomes: Polysomnography (PSG) measures including sleep efficiency (SE), sleep latency (SL), total sleep time (TST), wake after sleep onset (WASO), and delta power; and the Pittsburgh Sleep Quality Index (PSQI).
- Secondary Outcomes: Various sleep and stress-related scales (SSS, ESS, PSS, RSQ-W, FSS) and blood biomarkers such as melatonin, GABA, and serotonin levels.
- Safety: Monitored through adverse events, vital signs, and clinical laboratory tests.
- Conditions
- Sleep Quality, Sleep Wake Disorders
- Being tested
- Limosilactobacillus reuteri LM1063, Placebo
- Keywords
- probiotics, Limosilactobacillus reuteri, sleep health, L. reuteri LM1063, gut-brain axis
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limosilactobacillus reuteri LM1063Dietary supplement
A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10^10 CFU/day).
PlaceboDietary supplement
An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate..
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri LM1063 | Experimental | Participants in this arm will receive one capsule containing 500 mg of Limosilactobacillus reuteri LM1063 (1.0 x 10^10 CFU/day) once daily, one hour before bedtime for 8 weeks. Receives: Dietary Supplement: Limosilactobacillus reuteri LM1063 |
| Placebo | Placebo comparator | Participants in this arm will receive one placebo capsule (containing processed starch, etc.) identical in appearance to the test product, once daily, one hour before bedtime for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Sleep Efficiency (SE)
Measured as (Total Sleep Time / Time in Bed) x 100.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Sleep Latency (SL)
Time taken to fall asleep from lights out.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Total Sleep Time (TST)
Total minutes spent in sleep during the study period.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Wake After Sleep Onset (WASO)
Total minutes awake after sleep onset until final awakening.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Delta Power
EEG power density in the delta frequency band (2-4Hz) during sleep.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Secondary outcomes (9)
Change from Baseline in Stanford Sleepiness Scale (SSS)
The SSS is a 7-point scale used to assess acute sleepiness. It consists of 7 descriptive statements ranging from 1 to 7. Scores range from 1 to 7, where a higher score indicates a greater degree of sleepiness (worse outcome).
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Epworth Sleepiness Scale (ESS)
The ESS is used to assess general daytime sleepiness by evaluating the likelihood of dozing off in 8 different situations. Each situation is rated on a 4-point scale (0-3). Total scores range from 0 to 24, where a score of 11 or higher indicates abnormal excessive daytime sleepiness. Higher scores indicate greater daytime sleepiness (worse outcome).
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Perceived Stress Scale (PSS)
The PSS-10 consists of 10 items assessing the degree to which situations in life are appraised as stressful over the past month. Each item is rated on a 5-point Likert scale (0-4). Total scores range from 0 to 40, with higher scores indicating a higher level of perceived stress (worse outcome).
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Recovery after Sleep Questionnaire-Weekly (RSQ-W)
The RSQ-W evaluates the feeling of recovery and mood upon waking up and starting the day over the past 7 days. Participants self-rate each item on a scale of 1 to 5. Higher total or average scores indicate a better quality of restorative sleep (better outcome).
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Fatigue Severity Scale (FSS)
The FSS measures the severity of fatigue and its impact on daily activities over the past 2 weeks. It consists of 9 items, each rated on a 7-point scale (1-7). The fatigue score is the average of the 9 items (range 1-7), where a score of 4 or higher indicates severe fatigue. Higher scores indicate greater fatigue severity (worse outcome).
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Blood Melatonin Levels
Blood melatonin levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Blood Gamma-Aminobutyric Acid (GABA) Levels
Blood GABA levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Blood Serotonin Levels
Blood serotonin levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063.
Measured: Baseline (Day 0) and Week 8 (Day 56)
Incidence of Adverse Events and Safety Assessment
Evaluation of safety through the monitoring of Adverse Events (AEs), changes in vital signs, and clinical laboratory test results (hematology and blood chemistry).
Measured: Throughout the study period (Up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start14 Jul 2025
- Primary completion27 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lactomason Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498712
- Sponsor's protocol ID
- P2506-8877
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Limosilactobacillus Reuteri LM1063 Supplementation on the Improvement of Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07498712
- Acronym / sponsor ID
- P2506-8877
- Conditions
- Sleep Quality, Sleep Wake Disorders
- Keywords
- probiotics, Limosilactobacillus reuteri, sleep health, L. reuteri LM1063, gut-brain axis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lactomason Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 27 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
The purpose of this clinical trial is to evaluate the efficacy and safety of Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults. Based on the microbiota-gut-brain axis, this study aims to scientifically analyze whether the supplementation of this specific probiotic strain can enhance sleep quality.
Methodology:
This is a randomized, double-blind, placebo-controlled, single-center clinical trial. A total of 80 participants (40 in the test group and 40 in the control group) will be enrolled. Participants in the test group will consume 500 mg of L. reuteri LM1063 (1.0 x 10^10 CFU/day) once daily for 8 weeks, while the control group will receive a placebo.
Key Evaluations:
To assess sleep improvement, various parameters will be measured before and after the 8-week intake period:
- Primary Outcomes: Polysomnography (PSG) measures including sleep efficiency (SE), sleep latency (SL), total sleep time (TST), wake after sleep onset (WASO), and delta power; and the Pittsburgh Sleep Quality Index (PSQI).
- Secondary Outcomes: Various sleep and stress-related scales (SSS, ESS, PSS, RSQ-W, FSS) and blood biomarkers such as melatonin, GABA, and serotonin levels.
- Safety: Monitored through adverse events, vital signs, and clinical laboratory tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri LM1063 | Experimental | Dietary Supplement: Limosilactobacillus reuteri LM1063Participants in this arm will receive one capsule containing 500 mg of Limosilactobacillus reuteri LM1063 (1.0 x 10^10 CFU/day) once daily, one hour before bedtime for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive one placebo capsule (containing processed starch, etc.) identical in appearance to the test product, once daily, one hour before bedtime for 8 weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or female adults aged 19 to 65.
- Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher.
- Voluntarily agreed to participate and signed the informed consent form.
Key exclusion criteria (4 listed)
- Severe sleep disorders (Insomnia Severity Index ≥ 22 or ≤ 7).
- Medical conditions causing sleep disorders (Sleep apnea, Restless legs syndrome, Depression, Narcolepsy, etc.).
- Intake of medications affecting sleep within 1 month before the first visit.
- Intake of probiotics or fermented milk products within 1 month before the first visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limosilactobacillus reuteri LM1063A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10^10 CFU/day). | Dietary supplement | L. reuteri LM1063 |
| PlaceboAn identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.. | Dietary supplement | Placebo |
Primary outcome
Change from Baseline in Sleep Efficiency (SE)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Measured as (Total Sleep Time / Time in Bed) x 100.
Change from Baseline in Sleep Latency (SL)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Time taken to fall asleep from lights out.
Change from Baseline in Total Sleep Time (TST)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Total minutes spent in sleep during the study period.
Change from Baseline in Wake After Sleep Onset (WASO)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Total minutes awake after sleep onset until final awakening.
Change from Baseline in Delta Power
Time frame: Baseline (Day 0) and Week 8 (Day 56)
EEG power density in the delta frequency band (2-4Hz) during sleep.
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: Baseline (Day 0) and Week 8 (Day 56)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
9 secondary outcomes
Change from Baseline in Stanford Sleepiness Scale (SSS)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Epworth Sleepiness Scale (ESS)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Perceived Stress Scale (PSS)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Recovery after Sleep Questionnaire-Weekly (RSQ-W)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Fatigue Severity Scale (FSS)
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Blood Melatonin Levels
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Blood Gamma-Aminobutyric Acid (GABA) Levels
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Blood Serotonin Levels
Time frame: Baseline (Day 0) and Week 8 (Day 56)
Incidence of Adverse Events and Safety Assessment
Time frame: Throughout the study period (Up to 8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep Quality
Recruiting
IMST for Dementia Risk Reduction
Systolic Blood Pressure, Blood Pressure
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Active, not recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limosilactobacillus reuteri LM1063 in people with Sleep Quality and Sleep Wake Disorders, run by Lactomason Co., Ltd. at 1 site in South Korea.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 South Korea. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Na Jung (82-55-360-5988, ynltm0401@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Sleep Efficiency (SE) (time frame: Baseline (Day 0) and Week 8 (Day 56)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.