Unique ID issued by UMIN | UMIN000049791 |
---|---|
Receipt number | R000056711 |
Scientific Title | Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment |
Date of disclosure of the study information | 2023/02/09 |
Last modified on | 2023/06/30 11:03:29 |
Investigation of the effects by ingesting the food containing the lactic acid bacteria on gut environment
Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment
Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment
Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment
Japan |
Healthy male/female adults
Not applicable | Adult |
Others
NO
To investigate some kind of effect on gut environment by ingesting the food containing the lactic acid bacteria for 4 weeks.
Efficacy
Defecation frequency
1. Gut microbiota
2. Gut metabolites
3. Defecation status (the number of days, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
4. Abdominal symptoms (bloating, borborygmus, gas) at times other than defecation
5. Changes in laboratory values, adverse events and side effects
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
4
Prevention
Food |
Consumption of the test food (4 capsules per day) every day for 4 weeks.
Consumption of the test food (4 capsules per day) every day for 4 weeks.
Consumption of the test food (4 capsules per day) every day for 4 weeks.
Consumption of the test food (4 capsules per day) every day for 4 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old.
(2) Subjects who have a bowel evacuation for 3 to 5 times in a week
(3) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.
(1) Subjects who have a plan or who have taken the food containing lactic acid bacteria within a month before the trial start, which would affect the trial result.
(2) Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplement and/or health foods, which would affect the trial results for more than 3 times a week.
(3) Subjects who have a plan or who have taken medication within a month before the pre-test start, which would affect the trial result.
(4) Subjects who had undergone appendectomy.
(5) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(6) Subjects who are expected to undergo major changes in their living environment such as home and work during this trial.
(7) Subjects with irregular dietary habits.
(8) Subjects whose roomer is planning to join this trial.
(9) Subjects who take excessive alcohol.
(10) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(11) Pregnant, possibly pregnant, or lactating women.
(12) Subjects who are allergic to medicines and test foods (related to lactic acid bacteria).
(13) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial.
(14-16) Subjects who donated their blood components, and/or whole blood as below
- all subjects: 200 mL within a month
- males: 400 mL within the last 3 months
- females: 400 mL within the last 4 months to this trial.
(17-18) Subjects whose collected blood volume within the last 12 months would reach to the following criteria after adding the blood collection in this study;
- males: 1,200 mL
- females: 800 mL
(19) Others who have been determined ineligible by the principal/sub investigator.
40
1st name | Shinnosuke |
Middle name | |
Last name | Murakami |
Metagen, Inc.
Headquarters
9970052
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
+81-235-64-0330
research@metagen.co.jp
1st name | Shinnosuke |
Middle name | |
Last name | Murakami |
Metagen, Inc.
Headquarters
9970052
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
+81-235-64-0330
research@metagen.co.jp
Metagen, Inc.
ITO EN, LTD.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Daiwa Building, 3-3-10 Nihonbashihongoku-cho, Chuo-ku, Tokyo 103-0021, Japan
+81-3-6225-9005
IRB@cpcc.co.jp
NO
2023 | Year | 02 | Month | 09 | Day |
Unpublished
Completed
2022 | Year | 11 | Month | 24 | Day |
2022 | Year | 11 | Month | 18 | Day |
2023 | Year | 02 | Month | 10 | Day |
2023 | Year | 03 | Month | 10 | Day |
2022 | Year | 12 | Month | 15 | Day |
2023 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056711