Unique ID issued by UMIN | UMIN000037571 |
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Receipt number | R000042833 |
Scientific Title | A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms. |
Date of disclosure of the study information | 2020/11/15 |
Last modified on | 2023/06/07 10:39:32 |
A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.
A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.
A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.
A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.
Japan |
Healthy adult
Adult |
Others
NO
This study aims to examine the effect of food containing lactic acid bacteria on relief from ocular and nasal discomfort for 8 weeks.
Efficacy
Subject's nasal or ocular symptom in an environmental exposure unit(EEU).
(the number of sneezes and nose blowing, eye itching, watery eyes)
1.Visual analog scale(EEU)
(nasal blockage, nasal itching, throat symptoms, sleepiness, disturbance of daily living)
2.Visual analog scale(after exposure Japanese cedar pollen)
(the number of sneezes and nose blowing, nasal blockage, nasal itching, eye itching, watery eyes, throat symptoms, sleepiness, disturbance of daily living)
3.QOL questionnaire, diagnosis subject's noses, eosinophil of nasal mucus and skin questionnaire.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of food containing lactic acid bacteria for 8 consecutive weeks
Ingestion of placebo without lactic acid bacteria for 8 consecutive weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1)Males and females from 20 to 64 years of age.
(2)Subjects who complained of eye and nasal discomfort and judged tested positive for Japanese cedar pollen specific IgE.
(3)Subjects who are judged as suitable for the study by the investigator.
(4)Subjects who obtained the consent about participation in the study.
(5)Subjects who do not take antiallergic drug account for more than half of whole.
(1)Subjects who routinely take food or medicine containing lactic acid bacteria or natto bacteria.
(2)Subjects who have severe nasal and eye symptoms affecting judgement of discomfort.
(3)Subjects who routinely take medicines affecting the test result.
(4)Subjects who are under medication (specific desensitization therapy) which may influence the outcome of the study.
(5)Subjects who are engaged in drive a car or operate a hazardous machine.
(6)Subjects judged as unsuitable for the stuzy by the investigator for laboratory evidence or cardiopulmonary function.
(7)Subjects who have a disease requiring regular medication or a history of serious disease for which medication was required.
(8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(9)Subjects who are liable to cause an allergy related to the study.
(10)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(11)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(13)Subjects who are judged as unsuitable for the study by the investigator for other reason.
50
1st name | Yuhi |
Middle name | |
Last name | Saito |
KAMEDA SEIKA Co., Ltd.
Rice Research Center
950-0198
3-1-1, Kameda-KogyoDanchi, Konan-ku, Niigata-shi, Niigata
025-382-8879
yuuhi_saitou@sk.kameda.co.jp
1st name | Chiharu |
Middle name | |
Last name | Goto |
TTC Co., Ltd.
Clinical Research Planning Department
150-0021
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
c.goto@ttc-tokyo.co.jp
TTC Co., Ltd
KAMEDA SEIKA Co., Ltd.
Profit organization
Aisei Hospital Ueno Clinic Research Ethics Committee
2-18-6, Higashiueno, Taitou-ku, Tokyo
03-6455-0880
t.saito@ttc-smo.jp
NO
2020 | Year | 11 | Month | 15 | Day |
Unpublished
Completed
2019 | Year | 07 | Month | 25 | Day |
2019 | Year | 07 | Month | 25 | Day |
2019 | Year | 08 | Month | 03 | Day |
2019 | Year | 11 | Month | 21 | Day |
2019 | Year | 08 | Month | 01 | Day |
2023 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042833
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