UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038504 |
|---|---|
| Receipt number | 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 | 2020/02/21 13:38:20 |
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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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
80
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
| 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
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043815
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
