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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029210
Receipt No. R000033382
Scientific Title A verification study for improving the quality of sleep by Lactobacillus brevis SBC8803 (SBL88TM) intake: A randomized double-blind, parallel-group, placebo-controlled study
Date of disclosure of the study information 2017/09/20
Last modified on 2018/04/24

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Basic information
Public title A verification study for improving the quality of sleep by Lactobacillus brevis SBC8803 (SBL88TM) intake: A randomized double-blind, parallel-group, placebo-controlled study
Acronym A study for improving the quality of sleep by lactic acid bacteria SBL88TM intake
Scientific Title A verification study for improving the quality of sleep by Lactobacillus brevis SBC8803 (SBL88TM) intake: A randomized double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
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
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 09 Month 11 Day
Date of IRB
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

Other
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

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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