Unique ID issued by UMIN | UMIN000005398 |
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Receipt number | R000006409 |
Scientific Title | Effects of Continued Lactobacillus pentosus strain b240 Intake on Upper Respiratory Tract Infections in Elderly People |
Date of disclosure of the study information | 2011/04/07 |
Last modified on | 2011/04/07 16:19:34 |
Effects of Continued Lactobacillus pentosus strain b240 Intake on Upper Respiratory Tract Infections in Elderly People
Effects of Lactobacillus b240 on Upper Respiratory Tract Infections
Effects of Continued Lactobacillus pentosus strain b240 Intake on Upper Respiratory Tract Infections in Elderly People
Effects of Lactobacillus b240 on Upper Respiratory Tract Infections
Japan |
Common cold
Pneumology |
Others
NO
To evaluate the effects of foods containing b240 on upper respiratory tract infections and immunological parameters in healthy elderly people in an explorative manner
Safety,Efficacy
Incidence of common cold
1)Salivary SIgA secretion
2)QOL
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Placebo food, one tablet/day, 20 consecutive weeks.
Food containing 4x9E10 b240, one tablet/day, 20 consecutive weeks
Food containing 4x10E10 b240, one tablet/day, 20 consecutive weeks
65 | years-old | <= |
84 | years-old | >= |
Male and Female
Of the elderly individuals who gave informed consent in writing, those satisfying the requirements listed in 1) received screening test. The individuals judged by the Investigator or Sub-investigator as appropriate for the study were enrolled as subjects.
1)Healthy males and females aged over 65 at the time of acquisition of informed consent in writing
1)Smokers
2)Individuals practicing intensive exercise continuously
3)Individuals with laboratory parameters, blood pressure or heart rate markedly deviated from the normal range
4)Individuals with a history of gastrointestinal or immunological diseases, such as pneumonia, cancer, inflammatory bowel disease or rheumatism etc.
5)Individuals with bleeding or inflammation in the oral cavity
6)Individuals having received antibiotics during the period between 2 weeks before the screening test and the start of test food intake
7)Other individuals judged as inappropriate for the study by the physician in charge
300
1st name | |
Middle name | |
Last name | Shoji Shinkai |
Tokyo Metropolitan Geriatric Hospital
Social Participation and Regional Health Study Team
35-2 Sakae-cho, Itabashi-ku, Tokyo
03-3964-3241
1st name | |
Middle name | |
Last name | Masamichi Toba |
Otsuka Pharmaceutical Co., Ltd.
Otsu Nutraceuticals research institute
3-31-13 saigawa Otsu
077-521-8835
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Profit organization
JAPAN
NO
2011 | Year | 04 | Month | 07 | Day |
Unpublished
Completed
2010 | Year | 01 | Month | 15 | Day |
2010 | Year | 02 | Month | 01 | Day |
2011 | Year | 04 | Month | 07 | Day |
2011 | Year | 04 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006409
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