UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016812 |
|---|---|
| Receipt number | R000019420 |
| Scientific Title | A Clinical Study for Evaluating the Safety of Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria. |
| Date of disclosure of the study information | 2015/03/17 |
| Last modified on | 2015/11/16 16:06:23 |
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Basic information
Public title
A Clinical Study for Evaluating the Safety of Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Acronym
A Clinical Study for Evaluating the Safety of Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Scientific Title
A Clinical Study for Evaluating the Safety of Consumption of Beverages Containing Heat-killed Lactic Acid Bacteria.
Scientific Title:Acronym
A Clinical Study for Evaluating the Safety of 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 consumption of beverages containing heat-killed lactic acid bacteria for 12 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 4-week, 8-week, 12-week consumption and 4 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, 12 weeks consumption.
Interventions/Control_2
Beverages not containing heat-killed lactic acid bacteria, 12 weeks 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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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 | 17 | 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 | 03 | Month | 08 | 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 | 16 | Day |
Last modified on
| 2015 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019420
