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

What this Trial Is About

Researchers are evaluating the effects of the probiotic Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults aged 19 to 65. This trial aims to understand if this specific probiotic can enhance sleep quality by acting on the microbiota-gut-brain axis. The study is a randomized, double-blind, placebo-controlled trial conducted at a single center, enrolling 80 participants divided equally into test and control groups. Participants in the test group will take one 500 mg capsule containing L. reuteri LM1063 (1.0 x 10^10 CFU/day) once daily, one hour before bedtime, for 8 weeks. The control group will receive a placebo capsule identical in appearance and dosing schedule. Both groups follow the same 8-week intake period under close monitoring. Throughout the study, participants will undergo assessments of sleep quality using polysomnography measures such as sleep efficiency, latency, total sleep time, and wake after sleep onset, along with the Pittsburgh Sleep Quality Index. Secondary evaluations include sleepiness and stress scales, blood markers like melatonin, GABA, and serotonin, and safety monitoring through adverse events, vital signs, and lab tests. The study tracks changes from baseline at the start and after 8 weeks of treatment.

Effect of L. Reuteri LM1063 on Sleep Health Improvement