A verification study for improving the quality of sleep by Lactobacillus brevis SBC8803 (SBL88TM) intake: A randomized double-blind, parallel-group, placebo-controlled study - A study for improving the quality of sleep by lactic acid bacteria SBL88TM intake

ORTHOMEDICO Inc.0 sites200 target enrollmentSeptember 20, 2017

ConditionsHealthy Japanese adults

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese adults
Sponsor: ORTHOMEDICO Inc.
Enrollment: 200
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 20, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ORTHOMEDICO Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\.At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2\.Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or other chronic diseases 3\.Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4\.Currently taking medicines (include herbal medicines) and supplements 5\.Subjects who are allergic to medicines and/or the test food related products 6\.Subjects who are pregnant, breast\-feeding, and plan to become a pregnant 7\.Subjects who live with their infants less than 1 year old 8\.Subjects who co\-sleep with their children (1 to 6 years old) 9\.Subjects who live with requiring long\-term care persons 10\.Subjects who share the bed with more than one person 11\.Subjects who work late\-night shift and the life\-styles are irregular 12\.Subjects whose body mass index (BMI) is 25 kg/m2 or more 13\.Subjects who wake up for urination 3 times or more during nocturnal sleep 14\.Subjects whose dinner time is extremely irregular 15\.Subjects who are troubled with pollen allergy or asthma 16\.Subjects who drink alcohol heavily 17\.Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 18\.Subjects who are judged as ineligible to participate in the study by the principal investigator