Effect of L. Reuteri LM1063 on Sleep Health Improvement

NCT07498712 | Recruiting

• 1 other identifier: P2506-8877
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sleep Quality; Sleep Wake Disorders

Keywords

probiotics; Limosilactobacillus reuteri; sleep health; L. reuteri LM1063; gut-brain axis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Change from Baseline in Stanford Sleepiness Scale (SSS)

  Baseline (Day 0) and Week 8 (Day 56)

• Change from Baseline in Epworth Sleepiness Scale (ESS)

  Baseline (Day 0) and Week 8 (Day 56)

• Change from Baseline in Perceived Stress Scale (PSS)

  Baseline (Day 0) and Week 8 (Day 56)

• Change from Baseline in Recovery after Sleep Questionnaire-Weekly (RSQ-W)

  Baseline (Day 0) and Week 8 (Day 56)

• Change from Baseline in Fatigue Severity Scale (FSS)

  Baseline (Day 0) and Week 8 (Day 56)

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Limosilactobacillus reuteri LM1063 DIETARY_SUPPLEMENT

A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10\^10 CFU/day).

L. reuteri LM1063

Placebo DIETARY_SUPPLEMENT

An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate..

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lactomason Co., Ltd.: lead

Study Sites (1)

P&K Skin Research Center

Seoul, Yeongdeungpo, 07236, South Korea

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu-Na Jung

CONTACT

82-55-360-5988; ynltm0401@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: July 14, 2025
• Primary Completion: March 27, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)