UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We verify safety of excessive consumption of LTK-1 or LES-1 for 4 weeks (by taking 5 times of its normal dose).
Basic objectives2	Others
Basic objectives -Others	We verify safety of excessive consumption of LTK-1 or LES-1 for 4 weeks (by taking 5 times of its normal dose).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Appearance of adverse events
Key secondary outcomes	-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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	LTK-1 Intake 5 times of normal does of test food every day.
Interventions/Control_2	LES-1 Intake 5 times of normal does of test food every day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	40

Research contact person
Name of lead principal investigator	Akihito Yoshida
Organization	MEDOC Medical Dock & Clinic
Division name	internal medicine
Address	4-3,Yasudadori,Showa-ku, agoya-shi, Aichi, Japan
TEL	052-752-1135
Email	chiken@medoc.jp

Public contact
Name of contact person	Hiromichi Hayashi,Toru Urakawa
Organization	Medeical Fusion Co.,Ltd.
Division name	Clinical development division
Address	Adaptgenpharmaceutical.co.,LTD1-90-1,Kamiyama-cho,Tajimi-City,Gifu,Japan
TEL	052-745-3300
Homepage URL
Email	info@m-fusion.co.jp

Sponsor
Institute	Ichibiki Co., Ltd.
Institute
Department

Funding Source
Organization	Ichibiki Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人メドック健康クリニック（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 12 Month 12 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 27 Day
Last modified on	2018 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034407