Unique ID issued by UMIN | UMIN000047765 |
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Receipt number | R000054456 |
Scientific Title | Effects of consumption of the test beverage on the defecation in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/05/16 |
Last modified on | 2022/10/28 12:05:42 |
Effects of consumption of the test beverage on the defecation in healthy Japanese subjects
Effects of consumption of the test beverage on the defecation in healthy Japanese subjects
Effects of consumption of the test beverage on the defecation in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test beverage on the defecation in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test beverage on the bowel movement in healthy Japanese subjects whose defecation frequency is three to five times per week
Efficacy
Confirmatory
Pragmatic
Not applicable
1. Defecation frequency at the 2nd week after consumption of test beverage
1. Defecation frequency at the 1st week after consumption of test beverage
2. Numbers of defecation days and amount of defecation at the 1st and 2nd week after consumption of test beverage
3. Stool shape, stool smell, and exhilarating feeling of defecation at the 1st and 2nd week after consumption of test beverage
4. The score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w)
5. Each item of CAS at 2w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
2
Treatment
Food |
Duration: Two weeks
Test beverage: Beverage containing lactic acid bacteria and yeast
Administration: Drink one pack each before breakfast and dinner (two packs per day)
*Daily dose should be taken within the day. If you forget to take the test beverage, take it as soon as you remember within the day.
Duration: Two weeks
Test beverage: Placebo beverage
Administration: Drink one pack each before breakfast and dinner (two packs per day)
*Daily dose should be taken within the day. If you forget to take the test beverage, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects whose defecation frequency is three to five times per week
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects whose defecation frequency is relatively few during a week before the screening (before consumption)
1. Subjects who have drinkning habit on an empty stomach or who sometimes have diarrheal due to drinking
2. Subjects who are diarrheal tendency
3. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
4. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
5. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
6. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
7. Subjects who currently taking medications (including herbal medicines) and supplements
8. Subjects who are allergic to medicines and/or the test beverage related products
9. Subjects who are pregnant, lactation, or planning to become pregnant
10. Subjects who suffer from COVID-19
11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
12. Subjects who are judged as ineligible to participate in the study by the physician
30
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.
maikon no kohara Corporation.
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 Building, 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)
2022 | Year | 05 | Month | 16 | Day |
Unpublished
34
Completed
2022 | Year | 04 | Month | 20 | Day |
2022 | Year | 04 | Month | 20 | Day |
2022 | Year | 04 | Month | 28 | Day |
2022 | Year | 07 | Month | 30 | Day |
2022 | Year | 05 | Month | 16 | Day |
2022 | Year | 10 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054456
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