Unique ID issued by UMIN | UMIN000045531 |
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Receipt number | R000051985 |
Scientific Title | A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult |
Date of disclosure of the study information | 2021/09/21 |
Last modified on | 2022/03/29 10:10:31 |
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To exploratory assess the effects of consumption of lactic acid bacteria on the immune function in healthy Japanese adult
Safety,Efficacy
The immune indicator (cell surface marker, neutrophil phagocytosis, neutrophil sterilizing function, NK cell activity, and cytokines)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
The consumption of lactic acid bacteria powder for four weeks
The consumption of placebo powder for four weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
Subjects aged 20 or more and less than 65
1. Subjects who are undergoing medical treatment or have a serious medical history of any disease such as malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive organ, blood, endocrine system, or metabolic system
2. Subjects who have drug allergy and/or serious food allergy, or have medical history of them
3. Subjects who are pregnant, breast-feeding, and planning to become pregnant
4. Subjects who have autoimmune disease
5. Subjects who have used drugs which may influence immune function (including antiallergic drugs and antibiotics) at the period of screening, or take food containing specific bacteria such as bifidobacterium and lactic acid bacteria in daily
6. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
7. Subjects who have been taken 400 mL and more blood within 12 weeks before consumption of the test food, or 200 mL and more blood at the period of screening
8. Subjects who plan to receive vaccination for infectious diseases such as influenza or COVID-19 from after agreement to participate to the end of this trial
9. Subjects who are judged as ineligible to participate in the study based on the evaluation of the physician for any results such as participant' background, physical finding, consultation, physical examination, and clinical examination
100
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
MORINAGA MILK INDUSTRY CO., LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2021 | Year | 09 | Month | 21 | Day |
Unpublished
100
Completed
2021 | Year | 09 | Month | 15 | Day |
2021 | Year | 09 | Month | 15 | Day |
2021 | Year | 09 | Month | 21 | Day |
2021 | Year | 12 | Month | 10 | Day |
2021 | Year | 09 | Month | 21 | Day |
2022 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051985
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