UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040232 |
|---|---|
| Receipt number | 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 10:29:41 |
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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
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
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045184
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