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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016849
Receipt No. R000019416
Scientific Title A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Date of disclosure of the study information 2015/03/25
Last modified on 2015/11/16

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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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