L. reuteri LM1063 for improving sleep
Official title: Effect and Safety of Limosilactobacillus Reuteri LM1063 Supplementation on the Improvement of Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Run by Lactomason Co., Ltd. · NCT07498712 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Lactomason Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Yeongdeungpo) |
| Status | Recruiting |
| Started | July 14, 2025 |
| Main results expected | March 27, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07498712 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.