Unique ID issued by UMIN | UMIN000024673 |
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Receipt number | R000028383 |
Scientific Title | A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans |
Date of disclosure of the study information | 2016/11/01 |
Last modified on | 2017/12/28 10:49:07 |
A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans
A trial for improving the intestinal environment in humans
A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans
A trial for improving the intestinal environment in humans
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To verify the improvement of intestinal environment to ingest the test food.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. Enterobacterial flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium cluster XVIII, and Clostridium subcluster XIVa)
*1 Perform the test at 0 week and at 1 and 2 weeks after ingestion
1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*1 Perform the test at 0 week and at 1 and 2 weeks after the ingestion
2. Stool form scale
*2 Perform the test at 0 week and at 1 and 2 weeks after the ingestion
3. Bowel movement diary
*3 Record it when having bowel movements
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Duration: 2 weeks
Test material: White Lactic acid bacterium Onakani Yell
Dose: A bottle (65 mL) of per day
Administration: Drink it after breakfast, lunch or dinner.
Duration: 2 weeks
Test material: Placebo
Dose: A bottle (65 mL) of per day
Administration: Drink it after breakfast, lunch or dinner.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. Persons who defecate two to five times per week
1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who being treated or have medical history for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or lactic fermenting beverage and/or food
4. Subjects who currently take medicines (include herbal medicines) and/or supplements
5. Subjects who are allergic to medicines or relate to the test food of this trial
6. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period
7. Subjects who have enrolled into other clinical trials within the last 3 months before the date signed written informed consent in this trial
8. Subjects are judged as unsuitable for participating in this trial by physician for other reasons
40
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
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.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
White Food Industry Co. Ltd.
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック
Seishin-kai Medical Association Inc, Takara Medical Clinic.
2016 | Year | 11 | Month | 01 | Day |
Published
Iwasaki S, Yokoi K, Suzuki N, Yamashita S, Iio S, Takara T. Effects of a Drink Containing Lactobacillus casei on Improving the Intestinal Environment in People with Constipation-A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial-. Jpn Pharmacol Ther. 2017; 45(12): 1947-1962.
Completed
2016 | Year | 10 | Month | 24 | Day |
2016 | Year | 11 | Month | 02 | Day |
2016 | Year | 11 | Month | 01 | Day |
2017 | Year | 12 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028383
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