UMIN-CTR Clinical Trial

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)
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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
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