Unique ID issued by UMIN | UMIN000053752 |
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Receipt number | R000061341 |
Scientific Title | A verification study to evaluate the safety of continuous consumption of Enterococcus faecium WB2000: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2024/03/01 |
Last modified on | 2024/04/05 09:18:00 |
A verification study to evaluate the safety of continuous consumption of Enterococcus faecium WB2000
A verification study to evaluate the safety of continuous consumption of Enterococcus faecium WB2000
A verification study to evaluate the safety of continuous consumption of Enterococcus faecium WB2000: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study to evaluate the safety of continuous consumption of Enterococcus faecium WB2000
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the safety of consumption of Enterococcus faecium WB2000 at 50 mg per day for four weeks.
Safety
Confirmatory
Pragmatic
Not applicable
1. Individuals who experienced adverse events
1. Individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Prevention
Food |
Duration: Four weeks
Test food: Capsule containing lactic acid bacteria
Administration: Take one capsule per day with water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Four weeks
Test food: Placebo capsule (without lactic acid bacteria)
Administration: Take one capsule per day with water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Japanese
2. Men or women
3. Individuals aged 20 or more and less than 65
4. Healthy individuals
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims"
5. Individuals who are taking/using medications (including herbal medicines), internal quasi-drugs, and supplements
6. Individuals who are allergic to medicines and/or the test food related products
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
9. Individuals who are judged as ineligible to participate in this study by the physician
20
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
WAKAMOTO PHARMACEUTICAL CO., LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@takara-clinic.com
NO
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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2024 | Year | 03 | Month | 01 | Day |
Unpublished
22
No longer recruiting
2024 | Year | 02 | Month | 14 | Day |
2024 | Year | 02 | Month | 14 | Day |
2024 | Year | 03 | Month | 01 | Day |
2024 | Year | 05 | Month | 12 | Day |
2024 | Year | 03 | Month | 01 | Day |
2024 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061341
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