UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019264 |
|---|---|
| Receipt number | R000022246 |
| Scientific Title | Effect of daily ingestion of yogurt drink containing Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine in healthy adult volunteers: a randomized, double-blind, placebo-controlled, parallel group comparison study. |
| Date of disclosure of the study information | 2015/10/07 |
| Last modified on | 2015/10/07 14:10:36 |
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Basic information
Public title
Effect of daily ingestion of yogurt drink containing Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine in healthy adult volunteers: a randomized, double-blind, placebo-controlled, parallel group comparison study.
Acronym
Effect of daily ingestion of Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine.
Scientific Title
Effect of daily ingestion of yogurt drink containing Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine in healthy adult volunteers: a randomized, double-blind, placebo-controlled, parallel group comparison study.
Scientific Title:Acronym
Effect of daily ingestion of Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the clinical benefits of daily ingestion of yogurt drink containing Lactobacillus gasseri SBT2055 on antibody response to influenza vaccines for 16 weeeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Antibody titers to influenza vaccine
Key secondary outcomes
Natural Killer cell activity , leukocyte differential count, flow cytometric lymphocyte subset analysis , salivary sIgA, MIF, urinary 8-OHdG, produced IFN- alpha /beta by PBMC, expression level of antiviral mRNA in PBMC, proliferative capacity of T cells, frequency of occurrence of cold-like symptoms, plasma IgG and IgA
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 100g of yogurt drink containing Lactobacillus gasseri SBT2055 daily for 4 weeks prior to influenza vaccination and for 12 weeks after vaccination.
Interventions/Control_2
Ingestion of 100g of yogurt drink without Lactobacillus gasseri SBT2055 daily for 4 weeks prior to influenza vaccination and for 12 weeks after vaccination.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects who plan to get inoculated with influenza vaccine in the current financial year.
2.Subjects who agree to participate in the current study with written informed consent.
Key exclusion criteria
1.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine or metabolic disorders or affected with an infectious disease which is required to report to the authorities.
2.Subjects who are suspected to have acute infection such as influenza, etc.
3.Subjects who are under treatment for chronic inflammatory diseases, autoimmune diseases or allergies, etc.
4.Subjects who were vaccinated within 12 weeks prior to participating this study.
5.Subjects who have had anaphylactic reaction, etc. to influenza vaccine in the past.
6.Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries.
7.Pre- or post-menopausal women having complaints of obvious physical changes.
8.Subjects with unusually high or low blood pressure, or with abnormal hematological data.
9.Subjects with serious anemia.
10.Subjects with a history of allergy to medicine or food (especially dairy products, eggs or chicken meat).
11.Subjects who regularly take drugs which may affect the immune function Chinese herbal medicine, health food or supplements (mushrooms, seaweed, nucleic acids, yeast, lactobacillus, etc.)
12.Subjects who regularly take drugs for constipation or diarrhea.
13.Subjects who regularly take the products such as "Megumi Yogurt" "Megumi Drink Type" "Megumi 0 Fat" or other yogurt products from Megumi series of MEGMILK SNOW BRAND Co., Ltd.
14.Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
15.Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood component within 2 weeks prior to this study.
16.Subjects who are pregnant or expected to be pregnant, or lactating during the study.
17.Subjects who participate in other clinical trials within the last one month prior to this study.
18.Any other medical reasons judged by the principal investigator.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND Co., Ltd , Milk Science Research Institute
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
北海道情報大学 保健センター（北海道）
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 04 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 11 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2015 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022246
