Effect of L. Reuteri LM1063 on Sleep Health Improvement

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Sleep Efficiency (SE) — 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) — Baseline (Day 0) and Week 8 (Day 56)
  Time taken to fall asleep from lights out.
• Change from Baseline in Total Sleep Time (TST) — 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) — Baseline (Day 0) and Week 8 (Day 56)
  Total minutes awake after sleep onset until final awakening.
• Change from Baseline in Delta Power — 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 — 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.

Trial sites (1)

More Lactomason Co., Ltd. trials in South Korea