Unique ID issued by UMIN | UMIN000028195 |
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Receipt number | R000032252 |
Scientific Title | The verification study for safety evaluation of the test food long-term administration in human: a double-blind, randomized placebo-controlled and parallel study |
Date of disclosure of the study information | 2017/07/12 |
Last modified on | 2018/07/05 10:10:03 |
The verification study for safety evaluation of the test food long-term administration in human: a double-blind, randomized placebo-controlled and parallel study
The verification study for safety evaluation of the test food long-term administration in human
The verification study for safety evaluation of the test food long-term administration in human: a double-blind, randomized placebo-controlled and parallel study
The verification study for safety evaluation of the test food long-term administration in human
Japan |
Healthy Japanese adults
Not applicable | Adult |
Others
NO
To identify the safety of long-term administration of the test food, containing Bacillus subtilis
Safety
Confirmatory
Pragmatic
Not applicable
1. Body measuring / Physical examination
2. Urinalysis
3. Blood test
4. Questionnaire (the Likert scale)
5. Bowel movement diary
*1-4 Perform the test at 0 week and at 4, 8, and 12 weeks after ingestion
*5 Record when having the defecation from a week before screening test to a day before the final test
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Food |
Duration: 12 weeks
Test materials: Tablets containing Bacillus subtilis
Dose: 3 tablets per day
Administration: Take 3 tablets after breakfast with water. Do not chew tablets.
* Daily dose must be taken within the day. If you forget take tablets, take them as soon as you remember within the day.
Duration: 12 weeks
Test materials: Placebo
Dose: 3 tablets per day
Administration: Take 3 tablets after breakfast with water. Do not chew tablets.
* Daily dose must be taken within the day. If you forget take tablets, take them as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. Subjects who are judged as eligible to participate in the study by the principal investigator
3. Among the subjects who passed 2., select the participants according to the following rules
20s: 2 or more male and female, 30s: 2 or more male and female, 40s: 4 or more male and female, 50s: 4 or more male and female, 60 or more to less than 80 years old: 6 or more male and female
4. Select the participants as equal as possible from subjects who have loose stool *1, constipated subjects *2, and subjects who have normal stool *3
*1 Subjects whose weekly average of bristol scale score is more than 5
*2 Subjects who defecate 2 to 4 times per week
*3 Subjects whose weekly average of bristol scale score is less than 5 and defecate more than 4 times per week
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, irritable bowel syndrome (IBS) 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
*Particularly taking warfarin
5. Subjects who are allergic to medicines and/or the test food related products
*Particularly soybeans, natto allergy
6. Subjects who have lactose intolerance
7. Subjects who are pregnant, breast-feeding, and plan to become a pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
9. Subjects who are judged as ineligible to participate in the study by the principal investigator
36
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
ASAHI CALPIS WELLNESS CO., LTD.
Profit organization
Medical Corporation Seishinkai, Takara Medical Clinic
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 Medical Clinic (Tokyo, Japan)
2017 | Year | 07 | Month | 12 | Day |
Published
Kanzato H, Tsuda R, Nadaoka I, Yasue M, Suzuki N, Takara T. Safety Evaluation of Long-term Administration of Bacillus subtilis C-3102-containing Food in Healthy Subjects-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-. Jpn Pharmacol Ther 2018; 46(5): 883-896
Completed
2017 | Year | 07 | Month | 10 | Day |
2017 | Year | 07 | Month | 13 | Day |
2017 | Year | 07 | Month | 12 | Day |
2018 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032252
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