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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023932
Receipt No. R000027455
Scientific Title A study for investigating preventive effects of yogurt on the development of flulike symptoms
Date of disclosure of the study information 2016/09/10
Last modified on 2018/05/23

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Basic information
Public title A study for investigating preventive effects of yogurt on the development of flulike symptoms
Acronym A study for investigating preventive effects of yogurt on the development of flulike symptoms
Scientific Title A study for investigating preventive effects of yogurt on the development of flulike symptoms
Scientific Title:Acronym A study for investigating preventive effects of yogurt on the development of flulike symptoms
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to evaluate the influence of successive intake of yogurt on (1) prevention of the development of flulike symptoms, (2) immune responses and (3) health related quality of life.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative incidence of influenza
Key secondary outcomes Symptoms of the common cold (incidence, frequency and severity)
Immunological tests using bloods
Health related quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Consumption of yogurt for 16 weeks
Interventions/Control_2 non-consumption of yogurt for 16 weeks
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

Not applicable
Gender Female
Key inclusion criteria (1) Female subjects aged twenty or more
Licentiates working in medical institutes as health or welfare professional
(2) Subjects who can understand the purpose and the contents of this study, and can agree to participation in this study by letter
Key exclusion criteria (1) Pregnant women
(2) Subjects who contracted influenza during the period of July 2016 to the date of giving written informed consent
(3) Subjects who show allergic responses to dairy products
(4) Lactose intolerant subjects
(5) Subjects who are instructed to restrict calories by physician
(6) Subjects with a history of diseases involving the immune system (e.g. rheumatism, cancer, thyroid disorder, systemic erythematodes, myasthenia gravis, graves disease, scleroderma )
(7) Subjects who have participated in other clinical tests within the past three months
(8) Subjects who were judged inadequate by investigator for other reasons
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Saito
Organization Ehime University Graduate School of Medicine
Division name Department of Basic Nursing and Health Science
Zip code
Address 454 Shizukawa, Toon, Ehime
TEL 089-964-5111
Email saitoi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsu Kinoshita
Organization Institute of Community Life Sciences Co., Ltd.
Division name Social Epidemiology Institute
Zip code
Address 1383-2 hiraimachi, Matsuyama, Ehime
TEL 089-904-7811
Homepage URL
Email tetsu@shin-science.co.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Meiji 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
2016 Year 09 Month 10 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
2016 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 13 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
2016 Year 09 Month 05 Day
Last modified on
2018 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027455

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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