NCT07498712

Effect of L. Reuteri LM1063 on Sleep Health Improvement

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Lactomason Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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..

Timeline

• Start date: 2025-07-14
• Primary completion: 2026-03-27
• Completion: 2026-06-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: South Korea