UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016194 |
|---|---|
| Receipt number | 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 14:15:05 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018793
| 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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