Unique ID issued by UMIN | UMIN000038362 |
---|---|
Receipt number | R000043720 |
Scientific Title | The verification study for improving the intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial |
Date of disclosure of the study information | 2020/04/01 |
Last modified on | 2020/05/07 12:45:01 |
The verification study for improving the intestinal environment
The verification study for improving the intestinal environment
The verification study for improving the intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
The verification study for improving the intestinal environment
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the improving effects on the intestinal environment of intaking the test food
Efficacy
Confirmatory
Pragmatic
Not applicable
Defecation frequency per week
1. Numbers of defecation days per week
2. Amount of defecation per week
3. Shape of stool
4. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
5. Bristol Stool Scale
6. Occupancy rate of enteric bacteria
7. Actual bacterial count of Bifidobacterium
8. Fecal pH
9. Water content in feces
10. Organic acids in feces
11. Putrefactive products in feces
12. Bile acids in feces
13. Facial skin assessment
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: 2 weeks
Test food: Fermentation product of soy milk with lactic acid bacteria
Duration: 2 weeks
Test food: Lactic acid bacteria-free sour clotted soy milk made of soy milk and lactic acid
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who defecate three to five times per week
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects whose actual bacterial count of Bifidobacterium is not 0
5. Subjects who have relatively few defecation frequencies in a week before screening (before consumption)
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome (IBS), or any other chronic diseases
4. Subjects who daily take "Foods for Specified Health Uses", "Foods with Functional Claims", yogurt, lactic fermenting beverage, or other functional food/beverage. Particularly taking food/beverage effective in intestine regulating.
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, breast-feeding, and planning to become pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period
9. Subjects who are judged as ineligible to participate in the study by the physician
40
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
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.
KIKKOMAN SOYFOODS COMPANY
Profit organization
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@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)
2020 | Year | 04 | Month | 01 | Day |
Unpublished
44
Completed
2019 | Year | 10 | Month | 07 | Day |
2019 | Year | 10 | Month | 07 | Day |
2019 | Year | 10 | Month | 23 | Day |
2019 | Year | 12 | Month | 27 | Day |
2019 | Year | 10 | Month | 23 | Day |
2020 | Year | 05 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043720
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |