Unique ID issued by UMIN | UMIN000052825 |
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Receipt number | R000059990 |
Scientific Title | Effect of probiotics on serum sex-hormone concentration -an open-labeled pilot study- |
Date of disclosure of the study information | 2023/11/17 |
Last modified on | 2023/11/17 16:47:27 |
Effect of probiotics on serum sex-hormone concentration -an open-labeled pilot study-
Effect of probiotics on serum sex-hormone concentration -an open-labeled pilot study-
Effect of probiotics on serum sex-hormone concentration -an open-labeled pilot study-
Effect of probiotics on serum sex-hormone concentration -an open-labeled pilot study-
Japan |
Healthy
Adult |
Others
NO
To assess the effect of live cells of lactic acid bacteria (capsuled) on serum sex-hormone level
Efficacy
Confirmatory
Pragmatic
Not applicable
Change in serum testosterone level after 12-week intake period
Changes in following items after 12-week intake period:
body mass index,
body fat percentage,
bone mass,
serum estradiol,
fecal microbiota
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
YES
NO
NO
No need to know
1
Prevention
Food |
Intake of lyophilized lactic acid bacteria-containing capsule (2 capsules/day) for 12 weeks.
50 | years-old | <= |
75 | years-old | > |
Male and Female
Healthy male and female
1. Taking medicines for chronic disease
2. Predicted to be sick after screening
3. premenopausal women
4. Taking supplements that may affect the sex hormone levels and intestinal microbiota
5. Participation in any clinical trial within 90 days of the commencement of the trial
10
1st name | Masafumi |
Middle name | |
Last name | Noda |
Graduate School of Biomedical and Health Sciences, Hiroshima University
Probiotic Science for Preventive Medicine
734-8551
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, Japan
082-257-5288
bel@hiroshima-u.ac.jp
1st name | Masafumi |
Middle name | |
Last name | Noda |
Graduate School of Biomedical and Health Sciences, Hiroshima University
Probiotic Science for Preventive Medicine
734-8551
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, Japan
082-257-5288
bel@hiroshima-u.ac.jp
Hiroshima University
BioGaia Japan
Profit organization
Ethical Committee for Clinical Research of Hiroshima University
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.jp
NO
2023 | Year | 11 | Month | 17 | Day |
Unpublished
Open public recruiting
2023 | Year | 11 | Month | 14 | Day |
2023 | Year | 11 | Month | 15 | Day |
2023 | Year | 11 | Month | 17 | Day |
2025 | Year | 02 | Month | 28 | Day |
2023 | Year | 11 | Month | 17 | Day |
2023 | Year | 11 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059990
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