UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015614 |
|---|---|
| Receipt number | 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 11:00:16 |
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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
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
Naoko_Waki@kagome.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018143
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
