Unique ID issued by UMIN | UMIN000039236 |
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Receipt number | R000044690 |
Scientific Title | Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study |
Date of disclosure of the study information | 2020/01/23 |
Last modified on | 2023/03/16 09:28:51 |
Efficacy evaluation of a fermented milk drink
Efficacy evaluation of a fermented milk drink
Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study
Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study
Japan |
Subjects with a tendency for constipation
Adult |
Others
NO
Efficacy evaluation of a fermented milk drink on bowel movements, abdominal feelings, gut environments and gut microbiota of healthy adult with tendency for constipation
Efficacy
Bowel movements
Fecal characteristics
Abdominal feelings
Gut environments
Gut microbiota
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Fermented milk drink
1 bottle/day for 4 weeks
Placebo drink
1 bottle/day for 4 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Subjects with bowel movements between 3 to 5 times a weeks
2. Subjects having an ability to understand study purpose and detail with voluntary written informed consent
1. Subjects regularly taking laxatives or drugs effective on digestive systems
2. Subjects taking antibiotics or any drugs affect on microbiota
3. Subjects with severe diseases or metabolic diseases regardless under treatment or not
4. Subjects with chronic diseases and taking drug regularly
5. Subject with history of digestive diseases or digestive surgery
6. Subjects regularly taking any functional food products thought to be effective on constipation
7. Subjects unable to stop taking restricted food such as probiotics, prebiotics and any foods thought to be effective on constipation during test period
8. Subjects with drug or alcohol addiction, and history of these
9. Subjects regularly drinking a lot of alcohol
10. Subject unable to stop taking alcohol on the day before the screening test or sampling feces/ urine
11. Subjects with any food allergies
12. Subjects judged as unsuitable for the study participant on the screening test
13. Subjects participating or willing to participate in any other studies of food, drug and cosmetic
14. Pregnant or lactating women, and those who have possibility to become pregnant during the study period
15. Subjects judged as unsuitable for the study participant by principal investigator from other reasons
200
1st name | Satoru |
Middle name | |
Last name | Suzuki |
Shinagawa Season Terrace Health Care Clinic
Medical examination and treatment management family chief director
108-0075
5F Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo
03-3452-3382
satoru_suzuki@sempos.or.jp
1st name | Eiji |
Middle name | |
Last name | Yoshikawa |
KSO Corporation
Sales department
105-0023
7F Omodaka Bldg., 1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
Yakult Honsha Co.,Ltd.
Profit organization
Ethical Committee of Shinagawa Season Terrace Health Care Clinic
5F Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo
03-3452-3382
tomohiro_kogo@sempos.or.jp
NO
2020 | Year | 01 | Month | 23 | Day |
Unpublished
200
Delay expected |
delay in manuscript preparation
Completed
2019 | Year | 11 | Month | 21 | Day |
2019 | Year | 11 | Month | 21 | Day |
2020 | Year | 01 | Month | 26 | Day |
2020 | Year | 03 | Month | 08 | Day |
2020 | Year | 01 | Month | 23 | Day |
2023 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044690
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