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Recruiting NCT07498712

Effect of L. Reuteri LM1063 on Sleep Health Improvement

No phase Interventional Sleep Quality Sleep Wake Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Limosilactobacillus reuteri LM1063, Placebo.
Who it may be relevant to
Registry conditions: Sleep Quality, Sleep Wake Disorders. Basic parameters: 19 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect and Safety of Limosilactobacillus Reuteri LM1063 Supplementation on the Improvement of Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Overview

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.

Interventions

  • Dietary supplement Limosilactobacillus reuteri LM1063
    A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10\^10 CFU/day).
  • Dietary supplement Placebo
    An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate..

Primary outcome measures

  • Change from Baseline in Sleep Efficiency (SE) [Time frame: Baseline (Day 0) and Week 8 (Day 56)]
  • Change from Baseline in Sleep Latency (SL) [Time frame: Baseline (Day 0) and Week 8 (Day 56)]
  • Change from Baseline in Total Sleep Time (TST) [Time frame: Baseline (Day 0) and Week 8 (Day 56)]
  • Change from Baseline in Wake After Sleep Onset (WASO) [Time frame: Baseline (Day 0) and Week 8 (Day 56)]
  • Change from Baseline in Delta Power [Time frame: Baseline (Day 0) and Week 8 (Day 56)]
  • Change in Pittsburgh Sleep Quality Index (PSQI) Total Score [Time frame: Baseline (Day 0) and Week 8 (Day 56)]
Secondary outcome measures (9)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

South Korea · 1 center
  • P&K Skin Research Center — Seoul

Identifiers

NCT: NCT07498712 · P2506-8877

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗