UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009252 |
|---|---|
| Receipt number | 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 09:19:37 |
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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
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
Public contact
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
Sponsor or person
Institute
Fukushimura Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010862
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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