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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040232
Receipt No. R000045184
Scientific Title Enhancing effects of yogurt fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 on immune function
Date of disclosure of the study information 2020/05/20
Last modified on 2020/04/17

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Basic information
Public title Enhancing effects of yogurt fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 on immune function
Acronym Enhancing effects of yogurt on immune function
Scientific Title Enhancing effects of yogurt fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 on immune function
Scientific Title:Acronym Enhancing effects of yogurt on immune function
Region
Japan

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

Objectives
Narrative objectives1 To evaluate effects of yogurt on immune function: antibody production against influenza vaccine, morbidity and symptom of respiratory infection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Antibody titers specific to influenza vaccine antigen
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 (112mL) once a day for 13 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria [1] Individuals whose written informed consent has been obtained by themselves or from their parents.
[2] Healthy individuals over 18 years old.
[3] Individuals who live in the dormitory of the medical department of Juntendo university and who is going to get influenza vaccination conducted yearly by the university.
Key exclusion criteria [1] Individuals who were infected with influenza in the past 6 months
[2] Individuals who have diseases such as serious heart disease, kidney disease, hepatopathy, respiratory disease, cardiovascular disease, food allergy
[3] Individuals who have immunologic diseases such as malignant tumor, autoimmune disease, atopic dermatitis, asthma, inflammatory bowel disease
[4] Individuals who have lactose intolerance
[5] Individuals who had been participated in another clinical study in the past 1 month
[6] Individuals who are judged not suitable to participate in this trial by investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Sachio
Middle name
Last name Kawai
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 270-1695
Address 1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL 0467-98-1001
Email yssuzuki@juntendo.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 270-1695
Address 1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL 0467-98-1001
Homepage URL
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Juntendo University
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 Ethics committee of Juntendo University Graduate School of Sports and Health Science
Address 1-1, Hiragagakuendai, Inzai, Chiba, Japan
Tel 047-698-1001
Email sc-kyomu@juntendo.ac.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 20 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 49
Results
<Scientific conference>
Japanese Association for Food Immunology 2013

Serum antibody titer specific to H3N2 was significantly higher in test food group than placebo group.
Results date posted
2020 Year 04 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean(95%CI), p value

<Age>
Tested food group: 19.2(0.43), Placebo group: 19.5(0.7), p=0.488
<Height[m]>
Tested food group: 1.74(0.03), Placebo group: 1.73(0.02), p=0.442
<Weight[kg]>
Tested food group: 66.5(5.4), Placebo group: 64.9(2.8), p=0.617
<BMI[kg/m2]>
Tested food group: 22.0(1.7), Placebo group: 21.8(0.7), p=0.838
Participant flow
Recruited: 49
Randomized: 49

<Tested food group>
Allocated: 25
Excluded from analysis: 4 (3 for non-compliance with low ingestion rate and 1 for missing blood sampling)
Analyzed: 21

<Placebo group>
Allocated: 24
Dropped out: 1 (Refusal of vaccination)
Excluded from analyses: 4 (1 for non-compliance with low ingestion rate and 3 for missing blood sampling)
Analyzed: 19
Adverse events
None
Outcome measures
Geometric mean antibody titers specific to influenza vaccine antigen at -3, 1, 5, 8, 9 week after vaccination

<A H1N1 strain>
Tested food group: 61.4, 74.9, 118.9, 144.9, 115.0
Placebo group: 160.0, 111.1, 148.7, 148.7, 143.4
<A H3N2 strain>
Tested food group: 52.1, 74.9, 91.3, 135.7, 97.5
Placebo group: 53.6, 51.6, 55.5, 77.1, 62.0
<B strain>
Tested food group: 11.0, 35.1, 50.4, 36.2, 38.7
Placebo group: 8.6, 24.9, 38.6, 23.1, 28.8
Plan to share IPD None
IPD sharing Plan description None

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 11 Day
Date of IRB
2012 Year 10 Month 11 Day
Anticipated trial start date
2012 Year 10 Month 15 Day
Last follow-up date
2013 Year 01 Month 21 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=R000045184

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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