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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015614
Receipt No. R000018143
Scientific Title Effects of Lactobacillus brevis KB290 on incidence of influenza infection among schoolchildren
Date of disclosure of the study information 2014/11/06
Last modified on 2014/11/06

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Basic information
Public title Effects of Lactobacillus brevis KB290 on incidence of influenza infection among schoolchildren
Acronym Effects of Lactobacillus brevis KB290 on influenza
Scientific Title Effects of Lactobacillus brevis KB290 on incidence of influenza infection among schoolchildren
Scientific Title:Acronym Effects of Lactobacillus brevis KB290 on influenza
Region
Japan

Condition
Condition influenza
Classification by specialty
Infectious disease Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate whether a probiotic drink containing Lactobacillus brevis KB290 could reduce the incidence of influenza among elementary schoolchildren.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of subjects diagnosed with influenza by physicians (incidence of influenza)
Key secondary outcomes - Rate of subjects diagnosed with common cold by physicians (incidence of common cold)
- Rate of subjects diagnosed with gastroenteritis by physicians (incidence of gastroenteritis)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 A probiotic drink containing Lactobacillus brevis KB290
Interventions/Control_2 None
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
6 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Schoolchildren who meet both of the following conditions are required.
- Who belong to elementary schools in Nasushiobara city which agree to participate in this study.
- Whose guardians provide written informed consents.
Key exclusion criteria People who meet any of the following conditions are excluded.
- Who has a history of critical illness or is in therapy.
- Who is allergic to milk, soy, or apple.
- Who has a history of gastrointestinal surgery (excluding appendicitis).
- Who lives with employees of Kagome Co., Ltd.
- Who is judged disqualified to participate in this test by a leading physician of the test.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Suganuma
Organization Kagome Co., Ltd.
Division name Research & Development Division
Zip code
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Email Hiroyuki_Suganuma@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Waki
Organization Kagome Co., Ltd.
Division name Research & Development Division
Zip code
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Homepage URL
Email Naoko_Waki@kagome.co.jp

Sponsor
Institute Kagome Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nasuchuoh Hospital
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
2014 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/lam.12340/abstract
Number of participants that the trial has enrolled
Results
- Intake of a test drink containing Lactobacillus brevis KB290 reduced the incidence of influenza.
- We could not demonstrate the effects of a test drink on incidence of common cold or that of gastroenteritis.
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 Main results already published
Date of protocol fixation
2013 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 15 Day
Last follow-up date
2014 Year 03 Month 07 Day
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2014 Year 05 Month 31 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 11 Month 06 Day
Last modified on
2014 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018143

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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