UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of excessive consumption of Lactobacillus containing food in men and women.
Title of the study (Brief title)	Safety evaluation of excessive consumption of Lactobacillus containing food in men and women.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of excessive consumption of Lactobacillus containing food, 5-fold quantity of recommended daily intake.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/ body mass index Doctor's questions Adverse event Evaluate at points of 2-week and 4-week of consumption and 2 weeks after the end of consumption period.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of Lactobacillus-containing food 500 mg per day for 4 weeks.
Interventions/Control_2
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Males and females from 20 to 64 years of age
Key exclusion criteria	(1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease (2) Subjects having possibilities for emerging allergy related to the study (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) 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 (6) Subjects who intend to become pregnant or lactating (7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (8) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	Jiro Saito
Organization	Medical Station Clinic
Division name	None
Address	3-12-8 takaban, meguro-ku, Tokyo, Japan
TEL	03-6452-2712
Email	info@med-station.jp

Public contact
Name of contact person	Kazumi Tagami
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.tagami@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	KAMEDA SEIKA 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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 21 Day
Anticipated trial start date	2016 Year 04 Month 28 Day
Last follow-up date
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	2016 Year 04 Month 25 Day
Last modified on	2016 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025421