UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019266 |
|---|---|
| Receipt number | R000022275 |
| Scientific Title | Effect of lactic acid bacteria on symptoms of common cold: a randomized, double-blind, placebo-controlled study. |
| Date of disclosure of the study information | 2015/10/07 |
| Last modified on | 2015/10/19 10:08:42 |
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Basic information
Public title
Effect of lactic acid bacteria on symptoms of common cold: a randomized, double-blind, placebo-controlled study.
Acronym
Effect of lactic acid bacteria on symptoms of common cold: a randomized, double-blind, placebo-controlled study.
Scientific Title
Effect of lactic acid bacteria on symptoms of common cold: a randomized, double-blind, placebo-controlled study.
Scientific Title:Acronym
Effect of lactic acid bacteria on symptoms of common cold: a randomized, double-blind, placebo-controlled study.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of oral intake of lactic acid bacteria on symptoms of common cold.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence, number of subjects, duration, and symptom-scores of common cold
Key secondary outcomes
Salivary immunological test, defecation survey, QOL survey
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
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo (not containing lactic acid bacteria), 1 food per day for 12 weeks.
Interventions/Control_2
Lactic acid bacteria in low-dose, 1 food per day for 12 weeks.
Interventions/Control_3
Lactic acid bacteria in high-dose, 1 food per day for 12 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Females aged 18 and over.
2) Subjects willing and capable of giving written informed consent for study participation.
Key exclusion criteria
1) Subjects with serious hepatic dysfunction, renal dysfunction, cardiovascular disorder, gastrointestinal disorder, respiratory dysfunction, blood disease, endocrine disease, autoimmune disease, and these severe medical history.
2) Subjects who have severe allergic reaction to drugs, medicines and foods.
3) Subjects who constantly take functional foods and/or supplements containing high number of lactic acid bacteria and/or bifidobacteria.
4) Subjects who constantly take medicines affecting the test results.
5) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Kondo |
Organization
Kyushu Women's University
Division name
Faculty of home economics, Department of nutrition
Zip code
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
TEL
093-693-3125
junkondo@kwuc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Kondo |
Organization
Kyushu Women's University
Division name
Faculty of home economics, Department of nutrition
Zip code
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
TEL
093-693-3125
Homepage URL
junkondo@kwuc.ac.jp
Sponsor or person
Institute
Kyushu Women's University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
九州女子大学（福岡県）/ Kyushu Women's University
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 09 | 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
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2015 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022275
| Research Plan | |
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| 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 |
