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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013083
Receipt No. 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

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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
Email 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
Email sae.yanagihara@calpis.co.jp

Sponsor
Institute CALPIS Co.,Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015267

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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