[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631287":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Lactomason Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"L. reuteri LM1063","EXPERIMENTAL","Participants in this arm will receive one capsule containing 500 mg of Limosilactobacillus reuteri LM1063 (1.0 x 10\\^10 CFU\u002Fday) once daily, one hour before bedtime for 8 weeks.",[13],"Dietary Supplement: Limosilactobacillus reuteri LM1063",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants in this arm will receive one placebo capsule (containing processed starch, etc.) identical in appearance to the test product, once daily, one hour before bedtime for 8 weeks.",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Limosilactobacillus reuteri LM1063","A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10\\^10 CFU\u002Fday).",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate..",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Yu-Na Jung","CONTACT","82-55-360-5988","ynltm0401@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":26,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"P&K Skin Research Center","RECRUITING","Seoul","Yeongdeungpo","07236","South Korea",{"type":45,"coordinates":46},"Point",[47,48],126.9784,37.566,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":26,"email":54},"Hyun-ju Kim","82-70-4850-6440","hj.kim9@pnkskin.com",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100631287","effect-of-l-reuteri-lm1063-on-sleep-health-improvement-100631287",false,"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","Inclusion Criteria:\n\n* Healthy male or female adults aged 19 to 65.\n* Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher.\n* Voluntarily agreed to participate and signed the informed consent form.\n\nExclusion Criteria:\n\n* Severe sleep disorders (Insomnia Severity Index ≥ 22 or ≤ 7).\n* Medical conditions causing sleep disorders (Sleep apnea, Restless legs syndrome, Depression, Narcolepsy, etc.).\n* Intake of medications affecting sleep within 1 month before the first visit.\n* Intake of probiotics or fermented milk products within 1 month before the first visit.",true,"ALL","19 Years","65 Years",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73],"NA","Purpose:\n\nThe 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.\n\nMethodology:\n\nThis 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\u002Fday) once daily for 8 weeks, while the control group will receive a placebo.\n\nKey Evaluations:\n\nTo assess sleep improvement, various parameters will be measured before and after the 8-week intake period:\n\n* 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).\n* Secondary Outcomes: Various sleep and stress-related scales (SSS, ESS, PSS, RSQ-W, FSS) and blood biomarkers such as melatonin, GABA, and serotonin levels.\n* Safety: Monitored through adverse events, vital signs, and clinical laboratory tests.",[76,77],"Sleep Quality","Sleep Wake Disorders",[79,80,81,9,82],"probiotics","Limosilactobacillus reuteri","sleep health","gut-brain axis","2026-03-23",{"date":85,"type":86},"2026-03-27","ACTUAL",{"date":88,"type":86},"2025-07-14",{"date":90,"type":70},"2026-06-30",{"name":5,"class":6},1]