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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017274
Receipt No. R000020047
Scientific Title A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.
Date of disclosure of the study information 2015/04/25
Last modified on 2015/04/25

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Basic information
Public title A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.
Acronym A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.
Scientific Title A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.
Scientific Title:Acronym A Study for Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness and Immunological Response to Influenza Virus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Daily questionnaire symptoms based on influenza-like illness
Key secondary outcomes Immunological test using bloods collected before and after the intake period (10 weeks)

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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Lactic acid bacteria, 10 weeks consumption.
Interventions/Control_2 Placebo (not containing lactic acid bacteria), 10 weeks consumption
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
30 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria (1)Subjects aged 30 to 60 years old.
(2)Subjects giving written informed consent.
Key exclusion criteria (1)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
(2)Subjects taking any kind of medicine which affect the result of the trial for habitual use.
(3)Subjects daily consuming supplements or foods containing lactic acid bacteria.
(4)Pregnant women, lactating women.
(5)Alcoholics
(6)Subjects presenting known food allergy (milk allergy) and serious hay fever.
(7)Subjects attending other tests.
(8)Subjects with serious hepatic, renal, and cardiovascular dysfunction (including anamnesis).
(9)Subjects with anemic.
(10)Subjects who had received the influenza vaccination within the previous 18 months.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization Kirin 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 芝パレスクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 25 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
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 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
2015 Year 04 Month 25 Day
Last modified on
2015 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020047

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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