Unique ID issued by UMIN | UMIN000053684 |
---|---|
Receipt number | R000061264 |
Scientific Title | Study on Health Index Improvement of Personalized Probiotics ingestion modulating microbial metabolome. |
Date of disclosure of the study information | 2024/02/22 |
Last modified on | 2024/02/22 11:52:41 |
Study on Health Index Improvement of Personalized Probiotics ingestion modulating microbial metabolome.
Study on Health Index Improvement of Personalized Probiotics ingestion modulating microbial metabolome.
Study on Health Index Improvement of Personalized Probiotics ingestion modulating microbial metabolome.
Study on Health Index Improvement of Personalized Probiotics ingestion modulating microbial metabolome.
Japan |
Healthy Adults
Not applicable |
Others
NO
To determine the association between the gut microbiota, or metabolome, and health-related indicators in humans who consumed foods containing personalized lactic acid bacteria for eight weeks.
Efficacy
Health and lifestyle habits including defecation habits (bowel health) (questionnaire)
Diversity information on intestinal bacteria (genetic analysis of intestinal microbiota)
Fecal microbiome, and fecal SCFA (metabolome analysis)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Subjects consume the allocated lactobacillus-containing food daily for 8 weeks, either directly or with water.
19 | years-old | <= |
Not applicable |
Male and Female
1. Those who have been fully informed of the purpose and content of this research, have the capacity to consent, fully understand, and freely and voluntarily volunteer to participate in this research, and agree to participate in writing.
2. Japanese who are 19 years of age or older at the time of consent.
1. Those who have a chronic disease, are receiving medication, or have a history of serious illness
2. Those who are allergic to any of the foods used in this study
3. Those who have participated in other studies within one month prior to the start of this study, or who plan to participate in other studies after consenting to this study.
4. Those who are judged to be ineligible by the judgment of the supervising physician and principal investigator.
5. Those who is lactating, pregnant, or planning or desiring to become pregnant during the study period.
6. Those who do not consent to the analysis of fecal samples and the use of the study results for research purposes during the study period.
120
1st name | Takamasa |
Middle name | |
Last name | Masuda |
Healthcare Systems Co., Ltd.
Clinical Research Department
105-0004
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
masudat@hc-sys.jp
1st name | Takamasa |
Middle name | |
Last name | Masuda |
Healthcare Systems Co., Ltd.
Clinical Research Department
105-0004
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
masudat@hc-sys.jp
Healthcare Systems Co., Ltd.
HEM Pharma Inc
Profit organization
The Ethics Committee of Healthcare Systems Co., Ltd.
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
03-6809-2722
soumu@hc-sys.jp
NO
2024 | Year | 02 | Month | 22 | Day |
Unpublished
Preinitiation
2024 | Year | 02 | Month | 22 | Day |
2024 | Year | 02 | Month | 22 | Day |
2024 | Year | 08 | Month | 31 | Day |
2024 | Year | 02 | Month | 22 | Day |
2024 | Year | 02 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061264
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |