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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019266
Receipt No. 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

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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
Email 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
Email junkondo@kwuc.ac.jp

Sponsor
Institute Kyushu Women's University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022275

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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