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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016194
Receipt No. R000018793
Scientific Title The effect of the drink containing Lactobacillus powder on host immunity: a randomized, double blind, placebo-controlled study.
Date of disclosure of the study information 2015/01/13
Last modified on 2017/01/16

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Basic information
Public title The effect of the drink containing Lactobacillus powder on host immunity: a randomized, double blind, placebo-controlled study.
Acronym The effect of the drink containing Lactobacillus powder on host immunity: a randomized, double blind, placebo-controlled study.
Scientific Title The effect of the drink containing Lactobacillus powder on host immunity: a randomized, double blind, placebo-controlled study.
Scientific Title:Acronym The effect of the drink containing Lactobacillus powder on host immunity: 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 investigate to immune activation by the ingestion of the drink containing Lactobacillus powder, we evaluate immuno parameter, salivary s-IgA and life questionnaire (fever and cold-like symptoms).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes NK activity
Key secondary outcomes ・life questionnaire (fever and cold-like symptoms)
・salivary s-Ig A
・neutrophil phagocytosis function.
・lymphocyte blastoid transformation by Con-A

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 12week
1pack per day
Once a day
Administer study drugs to subjects within 12 weeks.
Interventions/Control_2 12week
1pack per day
Once a day
Administer placebo to subjects within 12 weeks.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria -Japanese males and females aged 30-65
-Those who are in low NK activity relatively.
Key exclusion criteria -Those believed to be ingesting a drug(s) that may influence test results
-Those believed to be routinely ingesting health food that may influence test results
-Those who are pregnant, likely to be pregnant, or breast-feeding
-Those who are Alcoholism
-Those who may have allergy to ingredients of the test material
-Participants in other clinical tests
-Those with a medical history of severe hepatic disorders, renal disorders, or cardiovascular diseases
-Those who have contracted or have hepatitis
-Those with severe anemia
-those who have inoculated influenza vaccine within 4 weeks .
-those who take a yogurt or a probiotic supplement
Target sample size 100

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 03-5408-1599
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 Asahi Group Holdings,Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor CALPIS Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 KRPS-16714
Org. issuing International ID_1 SOUKEN Co.,Ltd.
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 01 Month 13 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 Preinitiation
Date of protocol fixation
2015 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 16 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 01 Month 13 Day
Last modified on
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018793

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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