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.
Eligibility
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.
