UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019264
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022246

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.