UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Lactic Acid Bacterium for Sleeping Conditions
Acronym	Effect of Lactic Acid Bacterium for Sleeping Conditions
Scientific Title	Effect of Lactic Acid Bacterium for Sleeping Conditions
Scientific Title:Acronym	Effect of Lactic Acid Bacterium for Sleeping Conditions
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of lactic acid bacterium for sleeping conditions
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleep questionnaire (OSA sleep inventory MA version, Pittsburgh Sleep Quality Index (PSQI)), VAS for stress and fatigue, total sleep time
Key secondary outcomes	Profile of Mood States 2nd Edition, blood cortisol, blood DHEA-S, salivary cortisol, salivary chromogranin A, salivary SIgA concentration, salivary SIgA secretory rate, sleep and heart rate data measured by activity tracker

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of the test food (1 capsule /day; 4 weeks)
Interventions/Control_2	Intake of the placebo (1 capsule /day; 4 weeks)
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Healthy males and females aged 20-64 years. 2. Subjects who work from Monday to Friday and have Saturday and Sunday off 3. Subjects whose PSQI score at screening is over 6 points 4. Subjects who answer "before 24 o'clock" in Question 1 of the PSQI and "4 hours or more" in Question 4 at screening
Key exclusion criteria	1. Subjects who are undergoing medical treatment due to chronic disease 2. Subjects with drug or food allergies 3. Subjects who are pregnant, lactating, or intending to be pregnant 4. Subjects who have more than 60 g/day of alcohol per week 5. Subjects who have or have a history of sleep apnea syndrome (SAS) 6. Subjects who have or have a history of serious hepatic disorder, renal disorder, cardiac disorder, pulmonary disorder, gastrointestinal disorder, diabetes, etc 7. Subjects with severe rhinitis 8. Subjects who have participated in other clinical trials during the month before screening, or are willing to participate in the other clinical trials during this study 9. Subjecsts who are day and night shift workers or physical labors 10. Subjects who score 10 or more on QIDS-J 11. Subjects who take at least 3 days per week of drugs or health foods that may affect this study 12. Subjects who live with infants or caregivers and sleep in an environment that prevents them from sleeping regardless of their own will 13. Subjects who cannot use smartphones to transmit and manage data from wearable devices, or who cannot download and operate apps 14. Subjects who cannot wear or operate wearable devices 15. Subjects who have a habit of taking a nap for more than an hour on weekdays 16. Subjects judged inappropriate for this study by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81528382485
Email	i.takahashi@tes-h.co.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 03 Month 15 Day
Date of IRB	2021 Year 03 Month 24 Day
Anticipated trial start date	2021 Year 05 Month 30 Day
Last follow-up date	2021 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 10 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050268