UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013083 |
|---|---|
| Receipt number | R000015267 |
| Scientific Title | Examination of Immune Activation by Ingestion of the Yogurt "Life with Lactic Acid Bacteria" |
| Date of disclosure of the study information | 2014/02/05 |
| Last modified on | 2014/02/05 17:57:37 |
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Basic information
Public title
Examination of Immune Activation
by Ingestion of the Yogurt "Life with Lactic Acid Bacteria"
Acronym
Examination of Immune Activation
by Ingestion of the Yogurt "Life with Lactic Acid Bacteria"
Scientific Title
Examination of Immune Activation
by Ingestion of the Yogurt "Life with Lactic Acid Bacteria"
Scientific Title:Acronym
Examination of Immune Activation
by Ingestion of the Yogurt "Life with 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
An open test is performed to examine immune activation by ingestion of the yogurt "life with lactic acid bacteria" in order to evaluate a life survey (fever and cold-like symptoms). A defecation survey (improvement in bowel movement and properties of feces) and a questionnaire on gastrointestinal symptoms are also conducted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
life survey (fever and cold-like symptoms)
Key secondary outcomes
defecation survey (improvement in bowel movement and properties of feces)
questionnaire on gastrointestinal symptoms
Detection of influenza virus in saliva
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Term: 8 week
Amount: 1 cup per day
Frequency: Once a day
Interventions/Control_2
None
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Japanese males and females aged 20-59 at the time of receiving consent
-Those who tend to be in poor health condition during the period of January to March
-Those who have contracted influenza (excluding those who contracted influenza this year)
Key exclusion criteria
-Those believed to be ingesting a drug(s) that may influence test results (including those who were vaccinated before)
-Those believed to be routinely ingesting health food that may influence test results (food containing lactic acid bacteria)
-Those who are pregnant, likely to be pregnant, or breast-feeding
-Those who are drinking alcohol excessively
-Those who may be allergic to ingredients of the test material (milk, yogurt)
-Participants in other clinical tests
-Those with a medical history of severe hepatic disorders, renal disorders, or cardiovascular diseases
-Those who have contracted or have hepatitis
-Those with severe anemia
-Those with a disease of the digestive system
-Those judged disqualified to participate in this test by a leading physician of the test
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi SHINODA |
Organization
CALPIS Co.,Ltd
Division name
Research and Development Planning Department
Zip code
Address
5-11-10, Fuchinobe, Chuo-ku,
TEL
042-769-7811
tadashi.shinoda@calpis.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sae YANAGIHARA |
Organization
CALPIS Co.,Ltd.
Division name
Microbiology & Fermentation Laboratory
Zip code
Address
5-11-10, Fuchinobe, Chuo-ku,
TEL
042-769-7872
Homepage URL
sae.yanagihara@calpis.co.jp
Sponsor or person
Institute
CALPIS Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SOUKEN Co.,Ltd.
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
芝パレスクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 16 | 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
| 2014 | Year | 02 | Month | 05 | Day |
Last modified on
| 2014 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015267
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
