L. reuteri LM1063 for improving sleep
Effect and Safety of Limosilactobacillus Reuteri LM1063 Supplementation on the Improvement of Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
This trial will try a daily L. reuteri LM1063 probiotic to see if it helps adults (19–65) with poor sleep get better sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Lactomason Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Yeongdeungpo) |
| Trial ID | NCT07498712 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled single-center trial enrolling 80 healthy adults with poor sleep (PSQI ≥ 5). Participants will take 500 mg of L. reuteri LM1063 (1.0 x 10^10 CFU) or placebo once daily for 8 weeks. Sleep will be measured before and after the intervention using polysomnography and standard sleep questionnaires, focusing on measures such as sleep efficiency, sleep latency, total sleep time, and wake after sleep onset. The trial tests whether modulation of the gut-brain axis with this probiotic strain produces measurable changes in sleep quality.
Who should consider this trial
Good fit: Ideal candidates are otherwise healthy adults aged 19–65 with a PSQI score of 5 or higher who are not using sleep-affecting medications or recent probiotics.
Not a fit: People with severe sleep disorders, medical conditions that cause sleep problems, recent use of sleep medications or probiotics, or those outside the age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, the probiotic could modestly improve sleep quality and objective sleep measures in adults with poor sleep.
How similar studies have performed: Small prior studies of probiotics and the gut–brain axis have reported mixed and modest effects on sleep or mood, while this specific L. reuteri LM1063 strain has limited prior clinical evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Yeongdeungpo
- P&K Skin Research Center — Seoul, Yeongdeungpo, South Korea (Recruiting)
Study contacts
- Study coordinator: Yu-Na Jung
- Email: ynltm0401@gmail.com
- Phone: 82-55-360-5988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.