UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011476 |
|---|---|
| Receipt number | R000013432 |
| Scientific Title | Effects of jelly containing heat-killed lactic acid bacteria on immune function in elderly people |
| Date of disclosure of the study information | 2013/08/13 |
| Last modified on | 2014/07/17 15:04:25 |
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Basic information
Public title
Effects of jelly containing heat-killed lactic acid bacteria on immune function in elderly people
Acronym
Effects of heat-killed lactic acid bacteria on immune function
Scientific Title
Effects of jelly containing heat-killed lactic acid bacteria on immune function in elderly people
Scientific Title:Acronym
Effects of heat-killed lactic acid bacteria on immune function
Region
| Japan |
Condition
Condition
Influenza infection
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of jelly containing heat-killed lactic acid bacteria on immune parameters of protection against infection in elderly people.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Antibody titer and seroconversion against influenza vaccine.
Key secondary outcomes
Incidence rate of influenza, fever frequency, NK cell activity, neutrophil phagocytic activity, neutrophil bactericidal activity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Jelly containing heat-killed lactic acid bacteria, one cup per day, for 6 weeks
Interventions/Control_2
Placebo Jelly, one cup per day, for 6 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 residents of a nursing home, who are scheduled to receive influenza vaccination.
Key exclusion criteria
1) Residents with hepatic, renal, cardiovascular, respiratory and intestinal dysfunction.
2) Residents with allergy to soybean, peach and gelatin, which are contained in the tested foods.
3) Residents daily consuming supplements of lactic acid bacteria except those provided by meals.
4) Residents with inadequate oral intake of the tested foods.
5) Residents judged as inappropriate for the study by the physician in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Maruyama |
Organization
Tokyo Metropolitan Health and Medical Treatment Corporation Ohkubo Hospital
Division name
Department of Surgery
Zip code
Address
44-1 Kabukicho 2-chome Shinjuku-ku, Tokyo, Japan
TEL
03-5273-7711
mm.com@ohkubohospital.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Maruyama |
Organization
Tokyo Metropolitan Health and Medical Treatment Corporation Ohkubo Hospital
Division name
Department of Surgery
Zip code
Address
44-1 Kabukicho 2-chome Shinjuku-ku, Tokyo, Japan
TEL
03-5273-7711
Homepage URL
mm.com@ohkubohospital.jp
Sponsor or person
Institute
Clinico Co., Ltd.
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
| 2013 | Year | 08 | Month | 13 | 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
| 2013 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 04 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 13 | Day |
Last modified on
| 2014 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013432
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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