UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011476
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mm.com@ohkubohospital.jp

Sponsor
Institute Clinico Co., Ltd.
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.