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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009252
Receipt No. R000010862
Scientific Title Effects of jelly containing lactic acid bacteria on protection against infection and immune function in elderly people
Date of disclosure of the study information 2012/11/05
Last modified on 2013/03/27

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Basic information
Public title Effects of jelly containing lactic acid bacteria on protection against infection and immune function in elderly people
Acronym Effects of jelly containing lactic acid bacteria on protection against infection
Scientific Title Effects of jelly containing lactic acid bacteria on protection against infection and immune function in elderly people
Scientific Title:Acronym Effects of jelly containing lactic acid bacteria on protection against infection
Region
Japan

Condition
Condition common cold, infectious disease
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of jelly containing lactic acid bacteria on infectious diseases such as common cold and influenza virus infection in elderly people.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence, number of subjects and duration regarding symptoms of common cold (nose, throat, fever, pain) and infectious disease such as influenza virus infection.
Key secondary outcomes NK cell activity, neutrophil phagocytic activity, neutrophil bactericidal activity, antibody titers in response to the vaccine, immunoglobulin, salivary sIgA and composition of intestinal microbiota.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Jelly containing lactic acid bacteria, one cup per day, for 12 weeks
Interventions/Control_2 Placebo Jelly, one cup per day, for 12 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elderly individuals living in nursing care center, who are scheduled to receive influenza vaccination.
Key exclusion criteria 1) Individuals severely affected with hepatic dysfunction, renal dysfunction, cardiovascular disorder, respiratory dysfunction, endocrine disorder, metabolic disorder, intestinal obstruction, cancer and dyslipidemia.
2) Individuals with allergy to soybean, peach and gelatin, which are contained in the tested foods.
3) Individuals daily consuming supplements of lactic acid bacteria except those provided by meals.
4) Other individuals judged as inappropriate for the study by the physician in charge.
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Akatsu
Organization Fukushimura Hospital
Division name Choju Medical Institute
Zip code
Address 19-14, Aza-Yamanaka, Noyori, Toyohashi, Aichi, Japan
TEL 0532-46-7511
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroyasu Akatsu
Organization Fukushimura Hospital
Division name Choju Medical Institute
Zip code
Address 19-14, Aza-Yamanaka, Noyori, Toyohashi, Aichi, Japan
TEL 0532-46-7511
Homepage URL
Email

Sponsor
Institute Fukushimura Hospital
Institute
Department

Funding Source
Organization Clinico 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
2012 Year 11 Month 05 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
2012 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 05 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
2012 Year 11 Month 02 Day
Last modified on
2013 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010862

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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