UMIN-CTR Clinical Trial

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

N/A (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

[1]Antibody titers specific to influenza vaccine antigen
[2]Seroconversion rate
[3]Mean geometric increase
[4]Seroprotection

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

05

Month

10

Day

URL releasing protocol

N/A

Publication of results

Partially published

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

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 related information

Registered date

2020

Year

04

Month

24

Day

Last modified on

2020

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045197