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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044155
Receipt No. R000050268
Scientific Title Effect of Lactic Acid Bacterium for Sleeping Conditions
Date of disclosure of the study information 2021/05/14
Last modified on 2021/08/23

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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 No longer recruiting
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
2021 Year 08 Month 23 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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