Actively Recruiting
Effect of L. Reuteri LM1063 on Sleep Health Improvement
Led by Lactomason Co., Ltd. · Updated on 2026-03-27
80
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of L. Reuteri LM1063 on Sleep Health Improvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Severe sleep disorders (Insomnia Severity Index 64 22 or 64 7)
- Medical conditions causing sleep disorders such as sleep apnea, restless legs syndrome, depression, narcolepsy
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
P&K Skin Research Center
Seoul, Yeongdeungpo, South Korea, 07236
Actively Recruiting
Research Team
Y
Yu-Na Jung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here