UMIN-CTR Clinical Trial

Basic information
Public title	Enhancing effects of yogurt fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 on antibody production against influenza vaccine
Acronym	Enhancing effects of yogurt on antibody production
Scientific Title	Enhancing effects of yogurt fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 on antibody production against influenza vaccine
Scientific Title:Acronym	Enhancing effects of yogurt on antibody production
Region	Japan

Condition
Condition	N/A (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate enhancing effects of yogurt on antibody production against influenza vaccine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Antibody titers specific to influenza vaccine antigen [2]Seroconversion rate [3]Mean geometric increase [4]Seroprotection
Key secondary outcomes

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	Vaccine Food
Interventions/Control_1	Oral intake of test food or placebo (112 mL) once a day for 9 weeks
Interventions/Control_2	Vaccination with influenza vaccine after 3 weeks of intake
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	[1] Healthy adults aged 20-59 years [2] Individuals who are able to be vaccinated on schedule [3] Individuals whose BMI is 17-30 [4] Individuals whose written informed consent has been obtained
Key exclusion criteria	[1] Individuals who have gotten an allergic reaction to vaccination [2] Individuals who were vaccinated in either 2011/2012, 2012/2013 or 2013/2014 season [3] Individuals who were infected with influenza in either 2011/2012, 2012/2013 or 2013/2014 season [4] Individuals who were infected with influenza before vaccination [5] Individuals who have allergies to dairy products or lactose intolerance [6] Individuals who have a habit to take test food once a week or more in the past 3 months [7] Individuals who have allergies to foods or medicines [8] Individuals who have medical history of allergic diseases like pollinosis that require medications [9] Individuals who have immunodeficiency disease [10] Individuals who have medical history of malignant tumor [11] Individuals who have diabetes mellitus or dyslipidemia that require medications [12] Individuals who are taking medications for chronic diseases, which affect the result of this study [13] Individuals who have medical history of serious diseases that affect the result of this study [14] Individuals who participated in other clinical trials in the past 1 month or who are going to participate in other trials in this study period [15] Women who are going to be pregnant or breastfeeding in this study period [16] Individuals who are judged not suitable to participate in this trial by investigators
Target sample size	64

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Azuma
Organization	Yaesu Sakura-dori Clinic (Currently known as Nihonbashi Sakura Clinic)
Division name	Director
Zip code	103-0028
Address	3F Yaesu-center Building, 1-6-6 Yaesu, Chuo-ku, Tokyo, Japan
TEL	03-6801-8480
Email	info@tes-h.co.jp

Public contact
Name of contact person	1st name Toshiyasu Middle name Last name Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Research
Zip code	113-0033
Address	6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo Bunkyo-ku Tokyo, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
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	Yaesu Sakura-dori Clinic Institutional Review Board
Address	3F Yaesu-center Building, 1-6-6 Yaesu, Chuo-ku, Tokyo, Japan
Tel	03-6214-1285
Email	c-irb_ug@neues.co.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 10 Day

Related information
URL releasing protocol	N/A
Publication of results	Partially published

Result
URL related to results and publications	N/A
Number of participants that the trial has enrolled	120
Results	<Scientific conference> Japanese Association for Food Immunology 2014 Serum antibody titer specific to A H3N2 and B strain were significantly higher in tested food group than placebo group. Seroconversion rate of B strain was over 40 which was considered as positive only in tested food group.
Results date posted	2020 Year 04 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	<Age> Mean(95%CI), p value Tested food group: 43.8(3.6) Placebo group: 43.4(3.2) p=0.860 <Sex> Number(Ratio) Tested food group: Male 18(60.0%), Female 12(40.0%) Placebo group: Male 18(60.0%), Female 12(40.0%)
Participant flow	Recruited: 120 Randomized: 64 <Tested food group> Allocated: 32 Dropped out: 1 (Unvaccinated for having a fever) Excluded from analysis: 1 (Missing blood sampling) Analyzed: 30 <Placebo group> Allocated: 32 Dropped out: 1 (Discontinued) Excluded from analyses: 1 (Missing blood sampling) Analyzed: 30
Adverse events	Total number of adverse events: 26 Gastroenteritis: 3 Influenza: 1 Common cold: 16 Diarrhea: 1 Hemorrhoid: 1 Eczema: 1 Uterine fibroids and ovarian cyst resection: 1 Migraine: 1
Outcome measures	[1]Geometric mean antibody titers specific to influenza vaccine antigen 0, 3, 6, 12 weeks after vaccination <A H1N1 strain> Tested food group: 7.4, 145.9, 139.3, 91.9 Placebo group: 6.9, 121.3, 96.2, 74.6 <A H3N2 strain> Tested food group: 8.1, 71.3, 52.8, 39.1 Placebo group: 7.2, 60.6, 48.1, 36.5 <B strain> Tested food group: 8.9, 31.0, 27.6, 21.9 Placebo group: 12.6, 23.0, 22.4, 19.1 [2]Seroconversion rate <A H1N1 strain>Tested food group: 90.0%, Placebo group: 90.0% <A H3N2 strain>Tested food group: 70.0%, Placebo group: 56.7% <B strain>Tested food group: 46.7%, Placebo group: 40.0% [3]Mean geometric increase <A H1N1 strain>Tested food group: 20.6, Placebo group: 17.5 <A H3N2 strain>Tested food group: 8.4, Placebo group: 7.1 <B strain>Tested food group: 4.1, Placebo group: 3.0 [4]Seroprotection <A H1N1 strain>Tested food group: 90.0%, Placebo group: 90.0% <A H3N2 strain>Tested food group: 76.7%, Placebo group: 73.3% <B strain>Tested food group: 50.0%, Placebo group: 46.7%
Plan to share IPD	None
IPD sharing Plan description	None

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 12 Day
Date of IRB	2013 Year 09 Month 12 Day
Anticipated trial start date	2013 Year 09 Month 20 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 24 Day
Last modified on	2020 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045197

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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