UMIN-CTR Clinical Trial

Basic information
Public title	A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Acronym	A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Scientific Title	A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Scientific Title:Acronym	A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive consumption of beverage containing heat-killed lactic acid bacteria for 4 weeks in healthy adult
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Medical examination by blood biochemistry, hematology, urinalysis, physical examination at 2-week, 4-week consumption and 2 weeks after the end of consumption period.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Beverages containing heat-killed lactic acid bacteria, 4 weeks excessive consumption.
Interventions/Control_2	Beverages not containing heat-killed lactic acid bacteria, 4 weeks excessive consumption.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) (Healthy) subjects aged 20 to 64 years old. (2) Subjects giving written informed consent.
Key exclusion criteria	(1) Subjects with serious medical history of hepatic, renal, cardiovascular, respiratory and intestinal disease. (2) Subjects taking any kind of medicine which affect the result of the trial for habitual use. (3) Subjects daily consuming supplements or foods containing lactic acid bacteria. (4) Subjects presenting known food allergy or hay fever. (5) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Middle name Last name Haruhi Sugimura
Organization	C'est la vie Shimbashi Clinic
Division name	Medical office
Zip code
Address	2-39-3 Nishishimbashi, Minato-ku, Tokyo
TEL	03-5408-8671
Email	h-sugimura@shinkokai.jp

Public contact
Name of contact person	1st name Middle name Last name Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 20 Day
Last modified on	2015 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019416

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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