UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety excessive intake study of drink-A containing lactic acid bacteria
Title of the study (Brief title)	Safety excessive intake study of drink-A containing lactic acid bacteria
Region	Japan

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

Objectives
Narrative objectives1	Confirm the safety of the beverage containing Lactobacillus casei NY 1301 strain on healthy adults,3-fold quantity of recommended daily intake for 4 weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of side effects
Key secondary outcomes	Frequency of adverse events, Physical examination, Blood test, Urinalysis, Background factors, Lifestyle background

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of drink containing lactic acid bacteria for 4 weeks. (3-fold quantity of recommended daily intake)
Interventions/Control_2	Intake of placebo drink for 4 weeks.(3-fold quantity of recommended daily intake)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1)Subjects from 20 to 69 years-old 2)Subjects undergoing none of medical treatments 3)Subjects who can record daily logs daily during the designated period 4)Subjects who can record daily logs during the designated period 5)Subjects who can record diet records on specified days
Key exclusion criteria	1)Subjects with serious liver disease,renal /heart disease,organ disorder,diabetes,foodallergy,gastrointestinal disease,other serious diseases 2)Subjects allergic to a specific drug or food 3)Subjects allergic to samples in this study 4)Pregnants,lactating women or who is going to be pregnant during study 5)Subjects drawn blood over 200mL last 1 month,or over 400mL last3 months before consent acquisition date 6)Subjects who can't maintain everyday life habits 7)Subjects with a several variation of the amount of diet or movement 8)Subjects drink alcohol over 500mL in terms of beer per day 9)Subjects smoke over average 20 cigarettes per day 10)Subjects who can not refrain from using health foods,during the study 11)Subjects who can not take the test food as instructed 12)Subjects who have participated in the other clinical studies 13)Subjects judged as unsuitable for the study by the principal investigator for other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Moriyama
Organization	Kanazawabunko Hospital
Division name	Vice president
Address	2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama-shi,Kanagawa
TEL	045-785-3311
Email	watanabe@kanabun-hp.jp

Public contact
Name of contact person	Natsumi Oka
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Food Test Division
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo
TEL	03-6386-8809
Homepage URL
Email	n2-oka@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
Institute
Department

Funding Source
Organization	Nissin York 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	金沢文庫病院（神奈川県）、ゆきクリニック（東京都）、戸田中央総合病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 23 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	2018 Year 04 Month 17 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036815