Unique ID issued by UMIN | UMIN000030132 |
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Receipt number | R000034407 |
Scientific Title | A clinical study for evaluating safety of excessive consumption -Non-blind, safety verification study taking 5 times dose of foods contain lactic acid bacteria in healthy adults. |
Date of disclosure of the study information | 2017/12/01 |
Last modified on | 2018/03/30 09:06:38 |
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of foods contain lactic acid bacteria in healthy adults.
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of foods contain lactic acid bacteria in healthy adults.
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of foods contain lactic acid bacteria in healthy adults.
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of foods contain lactic acid bacteria in healthy adults.
Japan |
Healthy adults
Adult |
Others
NO
We verify safety of excessive consumption of LTK-1 or LES-1 for 4 weeks (by taking 5 times of its normal dose).
Others
We verify safety of excessive consumption of LTK-1 or LES-1 for 4 weeks (by taking 5 times of its normal dose).
Appearance of adverse events
-Height, weight and BMI
-Body temperature, blood pressure and pulse
-12-lead electrocardiogram
-General hematology test
-Blood biochemistry test
-Urinalysis
-Defecation status (times of defecation, amount of defecation, fecal properties)
-Special blood test
-Analysis of intestinal flora(stool tests)
-State of skin
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Prevention
Food |
LTK-1 Intake 5 times of normal does of test food every day.
LES-1 Intake 5 times of normal does of test food every day.
20 | years-old | <= |
45 | years-old | >= |
Male and Female
Target subject must satisfy the following selection criteria.
1)Healthy Japanese aged from 20 to 45 years-old at the time of giving informed consent
2)A person who is not using chronic or seasonal drugs or medical equipment and is not undergoing rehabilitation therapy
3)A person who has freely given informed consent and has fully understood the purpose of the study
4)A person whose BMI is from 18.5 to 30.0
5)When measuring blood pressure twice, a person whose average blood pressure is within a range of followings;Systolic blood pressure: less than or equal to 139mmHg
Diastolic blood pressure: less than or equal to 89mmHg
6)A person whose pulse rate is from 40 to 100 per minute
7)A person whose body temperature is from 35.5 to 37.0 degree Celsius
8)A person who can prevent from excessive exercise during the study
9)A person who can basically have 3 meals in a day during the study
10)A person who can conduct contraception by appropriate ways during the study
11)A person who understands and follows rules and requirements during the study
12)A person who is considered totally fit for participating the study by a comprehensive judgement of lead principal investigator and others
The following exclusion criteria apply to subjects.
1)A person with the disease in gastrointestinal tract, liver, kidney, heart and circulatory system which have an influence on the absorption, distribution, metabolism and excretion of test food
2)A person with a major surgery history in the gastrointestinal tract sites such as gastrectomy, stomach and intestines suture, the intestinal resection (however, polypectomy, the appendectomy are excluded)
3)A person with a history of cerebrovascular disorder (the asymptomatic lacunar infarct is excluded)
4)A person with tattoo which has an influence on the study because of its size or range
5)A person with hypersensitivity or idiosyncrasy, such as food allergy
6)A person who is suspected to have alcohol or drug dependence
7)A person who has participated in other clinical trials within 84 days from giving an informed consent
8)A person who donated 400 ml of blood within 84 days, 200 ml within 28 days, or a blood component (plasma or platelets) within 14 days from giving an informed consent
9)A nursing or pregnant woman
10)A person who is engaged in night duty
40
1st name | |
Middle name | |
Last name | Akihito Yoshida |
MEDOC Medical Dock & Clinic
internal medicine
4-3,Yasudadori,Showa-ku, agoya-shi, Aichi, Japan
052-752-1135
chiken@medoc.jp
1st name | |
Middle name | |
Last name | Hiromichi Hayashi,Toru Urakawa |
Medeical Fusion Co.,Ltd.
Clinical development division
Adaptgenpharmaceutical.co.,LTD1-90-1,Kamiyama-cho,Tajimi-City,Gifu,Japan
052-745-3300
info@m-fusion.co.jp
Ichibiki Co., Ltd.
Ichibiki Co., Ltd.
Profit organization
NO
医療法人メドック健康クリニック(愛知県)
2017 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 01 | Day |
2017 | Year | 12 | Month | 12 | Day |
2018 | Year | 02 | Month | 28 | Day |
2017 | Year | 11 | Month | 27 | Day |
2018 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034407
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