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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005398
Receipt No. R000006409
Scientific Title Effects of Continued Lactobacillus pentosus strain b240 Intake on Upper Respiratory Tract Infections in Elderly People
Date of disclosure of the study information 2011/04/07
Last modified on 2011/04/07

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Basic information
Public title Effects of Continued Lactobacillus pentosus strain b240 Intake on Upper Respiratory Tract Infections in Elderly People
Acronym Effects of Lactobacillus b240 on Upper Respiratory Tract Infections
Scientific Title Effects of Continued Lactobacillus pentosus strain b240 Intake on Upper Respiratory Tract Infections in Elderly People
Scientific Title:Acronym Effects of Lactobacillus b240 on Upper Respiratory Tract Infections
Region
Japan

Condition
Condition Common cold
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of foods containing b240 on upper respiratory tract infections and immunological parameters in healthy elderly people in an explorative manner
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of common cold
Key secondary outcomes 1)Salivary SIgA secretion
2)QOL

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Placebo food, one tablet/day, 20 consecutive weeks.
Interventions/Control_2 Food containing 4x9E10 b240, one tablet/day, 20 consecutive weeks
Interventions/Control_3 Food containing 4x10E10 b240, one tablet/day, 20 consecutive weeks
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
84 years-old >=
Gender Male and Female
Key inclusion criteria Of the elderly individuals who gave informed consent in writing, those satisfying the requirements listed in 1) received screening test. The individuals judged by the Investigator or Sub-investigator as appropriate for the study were enrolled as subjects.
1)Healthy males and females aged over 65 at the time of acquisition of informed consent in writing
Key exclusion criteria 1)Smokers
2)Individuals practicing intensive exercise continuously
3)Individuals with laboratory parameters, blood pressure or heart rate markedly deviated from the normal range
4)Individuals with a history of gastrointestinal or immunological diseases, such as pneumonia, cancer, inflammatory bowel disease or rheumatism etc.
5)Individuals with bleeding or inflammation in the oral cavity
6)Individuals having received antibiotics during the period between 2 weeks before the screening test and the start of test food intake
7)Other individuals judged as inappropriate for the study by the physician in charge
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Shinkai
Organization Tokyo Metropolitan Geriatric Hospital
Division name Social Participation and Regional Health Study Team
Zip code
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL 03-3964-3241
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masamichi Toba
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Otsu Nutraceuticals research institute
Zip code
Address 3-31-13 saigawa Otsu
TEL 077-521-8835
Homepage URL
Email

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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
2011 Year 04 Month 07 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
2010 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 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
2011 Year 04 Month 07 Day
Last modified on
2011 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006409

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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