Effect of L. Reuteri LM1063 on Sleep Health Improvement

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.

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 Overview

• Status: Recruiting
• Conditions: Sleep Wake Disorders; Sleep Quality
• Intervention / Treatment: Dietary supplement: Limosilactobacillus reuteri LM1063; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Na Jung; Phone Number: 82-55-360-5988; Email: ynltm0401@gmail.com

Study Locations

• South Korea
  • Yeongdeungpo
    • Seoul, Yeongdeungpo, South Korea, 07236
      • Recruiting
      • P&K Skin Research Center
      • Contact: Hyun-ju Kim; Phone Number: 82-70-4850-6440; Email: hj.kim9@pnkskin.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L. reuteri LM1063; 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.	Dietary supplement: Limosilactobacillus reuteri LM1063; A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10^10 CFU/day).
Placebo Comparator: Placebo; 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.	Dietary supplement: Placebo; An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Sleep Efficiency (SE)	Measured as (Total Sleep Time / Time in Bed) x 100.	Baseline (Day 0) and Week 8 (Day 56)
Change from Baseline in Sleep Latency (SL)	Time taken to fall asleep from lights out.	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.	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.	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.	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.	Baseline (Day 0) and Week 8 (Day 56)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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.	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.	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.	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).	Throughout the study period (Up to 8 weeks)

Collaborators and Investigators

• Sponsor: Lactomason Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Estimated): March 27, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: probiotics; gut-brain axis; Limosilactobacillus reuteri; sleep health; L. reuteri LM1063
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
• Other Study ID Numbers: P2506-8877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No