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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038504
Receipt No. R000043815
Scientific Title A verification study for the efficacy of SBL88TM intake on improving task performance: an open-label trial
Date of disclosure of the study information 2019/11/07
Last modified on 2019/11/08

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Basic information
Public title A verification study for the efficacy of SBL88TM intake on improving task performance
Acronym A verification study for the efficacy of SBL88TM intake on improving task performance
Scientific Title A verification study for the efficacy of SBL88TM intake on improving task performance: an open-label trial
Scientific Title:Acronym A verification study for the efficacy of SBL88TM intake on improving task performance
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of SBL88TM intake on improving task performance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The measured values on scores for each category of OSA sleep inventory MA version (OSA-MA; five categories) at four weeks after the start of test-food consumption (4w)

2. The measured values on scores for each item of OSA-MA (16 items) at 4w

3. The measured values of subjective symptom scores based on the VAS item scores at 4w

4. The measured values of work efficiency test (Advanced Trail Making Test; ATMT) at 4w
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 <Group1>
Duration: 2 weeks
Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells)
Administration: One tablet per day at any time during the day

<Group2>
Duration: 4 weeks
Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells)
Administration: One tablet per day at any time during the day

<Group3>
Duration: 4 weeks
Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells)
Administration: One tablet per day at any time during the day
Interventions/Control_2
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. Subjects who are affiliated with Sapporo Group or ORTHOMEDICO Inc.

2. Healthy Japanese adult subjects

3. Subjects who are judged as eligible to participate in the trial by the physician

4. Subjects who can participate in the trial according to the schedule

5. Subjects who voluntary give their consent to participate in the trial
Key exclusion criteria 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction

2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake

5. Subjects regularly taking medications (including herbal medicines) and supplements

6. Subjects allergic to medications and/or the test-food-related products

7. Subjects who are pregnant, lactating, or intending to become pregnant

8. Subjects who live with their infants less than 1 year old

9. Subjects who co-sleep with their children (1 to 6 years old)

10. Subjects who live with requiring long-term care persons

11. Subjects who share the bed with more than one person

12. Subjects who work late-night shift and the life-styles are irregular

13. Subjects who wake up for urination three 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 invitation to participate in this trial, or plan to participate in another trial during this trial

18. Subjects who are judged by the physician as ineligible to participate in the trial
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
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 Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
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 WELLNESS LAB LIMITED
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 The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.com

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
2019 Year 11 Month 07 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 25 Day
Date of IRB
2019 Year 10 Month 25 Day
Anticipated trial start date
2019 Year 11 Month 08 Day
Last follow-up date
2019 Year 12 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 06 Day
Last modified on
2019 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043815

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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