Unique ID issued by UMIN | UMIN000034239 |
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Receipt number | R000039026 |
Scientific Title | Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria |
Date of disclosure of the study information | 2018/09/23 |
Last modified on | 2020/03/24 10:50:16 |
Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria
Inhibition of allergy by intake of lactic acid bacteria
Inhibition of cedar pollen allergy by continuous intake of lactic acid bacteria
Inhibition of allergy by intake of lactic acid bacteria
Japan |
Not applicable
Clinical immunology | Adult |
Others
NO
To evaluate the anti-allergic effects of lactic acid bacteria on healthy adults who have had allergic symptoms that seems to be caused by cedar pollen
Efficacy
Symptoms caused by cedar pollen
Nasal cavity findings, Nasal eosinophil score, Serum cytokine etc.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Lactic acid bacteria, one tablet/day, 8 consecutive weeks
Placebo, one tablet/day, 8 consecutive weeks
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1) Subjects who obtained written consent regarding participation in research
2) Healthy adults aged 20 years or over, 65 years old or younger at the time of consent acquisition
3) Subjects who do not appear symptoms of allergic rhinitis in a period of not scattering cedar pollen, and do not need the medications
4) Subjects who the cedar pollen-specific IgE value is 2 or more
5) Subjects judged as appropriate for the study by the investigator in the medical examination
1) Pregnant women or women with potential for pregnancy, and women who want pregnancy during this study
2) Lactating women
3) Subjects with severe disease of respiratory disease, heart disease, liver disease, kidney disease, diabetes, autoimmune disease or those with a past history
4) Subjects who have acute rhinitis, sinusitis, hypertrophic rhinitis
5) Subjects who have bronchial asthma combined
6) Those who are undergoing treatment (sublingual immunotherapy, etc.) that affects the results of the study
7) Subjects receiving treatment for antihistamines, anti-leukotriene drugs, steroids for nasal spray, oral steroids, immunotherapy
8) Subjects with milk allergy
9) Subjects who regularly intake foods rich in lactic acid bacteria (kimchi, pickles, beverages containing lactic acid bacteria, yoghurt, food for specified health uses, foods with function claims, supplements) and pharmaceuticals (Biofermin, etc)
10) Subjects who regularly intake anti-allergic foods
11) Subjects who make a blood donation of 400 ml within 12 weeks before the preliminary medical examination or that of 200 ml within 4weeks before the preliminary medical examination
12) Subjects who are estimated inappropriate to this study by the principal investigator and the principal researcher.
48
1st name | Tadao |
Middle name | |
Last name | Enomoto |
NPO Japan Health Promotion Supporting Network
Not applicable
640-8269
TE Build. 5F, 3-68, Komatsubaradori, Wakayama
073-432-3005
t-enomoto@tempo.ocn.ne.jp
1st name | Takao |
Middle name | |
Last name | Saito |
Otsuka Pharmaceutical Co.,Ltd.
Otsu Nutraceuticals Research Institute
520-0002
3-31-13 Saigawa Otsu, Shiga
077-521-8835
Saito.Takao@otsuka.jp
Otsuka Pharmaceutical Co.,Ltd.
Otsuka Pharmaceutical Co.,Ltd.
Profit organization
NPO Japan Health Promotion Supporting Network
Medical corporation Sanyuukai Abe Clinic
Nippori Ekimaechuo Building 5F, 6-60-10, Higashinippori, Arakawa-ku, Tokyo, 116-0014
03-5810-7808
abecl-rinri@medicos-group.com
NO
2018 | Year | 09 | Month | 23 | Day |
Unpublished
Completed
2018 | Year | 09 | Month | 12 | Day |
2018 | Year | 09 | Month | 19 | Day |
2018 | Year | 09 | Month | 24 | Day |
2018 | Year | 12 | Month | 09 | Day |
2018 | Year | 09 | Month | 22 | Day |
2020 | Year | 03 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039026
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