UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study for improving the quality of sleep by Lactobacillus brevis SBC8803 (SBL88TM) intake: A randomized double-blind, parallel-group, placebo-controlled study
Title of the study (Brief title)	A study for improving the quality of sleep by lactic acid bacteria SBL88TM intake
Region	Japan

Condition
Condition	Healthy Japanese adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Lactobacillus brevis SBC8803 (SBL88TM) intake on quality of sleep.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. OSA sleep inventory MA version *Fill it in immediately after waking up at home on the examination day and two days before
Key secondary outcomes	1. Sleep test (Sleep Scan) 2. Athens Insomnia Scale (AIS) 3. Japanese version of Epworth Sleepiness Scale (JESS) 4. Beck Depression Inventory 5. Visual Analogue Scale (VAS) of subjective symptoms *1 Perform it at subject's home 1 week before screening and examination and during the test period *2-5 Assess these at 0 and 4 weeks after consuming

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 4weeks Test materials: Lactobacillus brevis SBC8803 (SBL88TM) sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Dose: Take a tablet once a day Administration: Take a tablet at optional timing. *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 4 weeks Test materials: Placebo Dose: Take a tablet once a day Administration: Take a tablet at optional timing. *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adults 2. Subjects who feel quality of sleep dissatisfaction 3. Subjects who are judged as eligible to participate in the study by the principal investigator 4. Subjects who are considered as appropriate for the study by the principal investigator based on the score of Beck Depression Inventory 5. Among the subjects who passed 3. and 4., subjects who have a relatively lower score of OSA sleep inventory MA version at screening and examination before ingestion
Key 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
Target sample size	200

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	SAPPORO HOLDINGS LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 11 Day
Anticipated trial start date	2017 Year 09 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 20 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033382