UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028636 |
|---|---|
| Receipt number | R000032773 |
| Scientific Title | The study of the effects of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the immunity function in elderly persons |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2017/08/10 21:14:44 |
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Basic information
Public title
The study of the effects of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the immunity function in elderly persons
Acronym
The study of the effects of yogurt on the immunity function
Scientific Title
The study of the effects of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the immunity function in elderly persons
Scientific Title:Acronym
The study of the effects of yogurt on the immunity function
Region
| Japan |
Condition
Condition
weakened immune systems
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the effect that a yogurt intake gives in salivary IgA
Basic objectives2
Others
Basic objectives -Others
Elucidation whether or not a yogurt intake increases total salivary IgA.
Elucidation whether or not a yogurt intake increases salivary IgA intersecting to influenza virus.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
salivary IgA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The participants ingested 100 g of yogurt fermented with L. bulgaricus OLL1073R-1 each day in the morning for 12 weeks.
Interventions/Control_2
The participants ingested 100 g of yogurt fermented with other lactobacillus each day in the morning for 12 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| 105 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly volunteers residing in elderly nursing homes
Key exclusion criteria
Individuals taking antibiotics or morphine, with gastric fistulae, who disliked yogurt
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Tsukinoki |
Organization
Kanagawa Dental University, Graduate School of Dentistry
Division name
Environmental Pathology
Zip code
Address
82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
TEL
046-822-8866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Yamamoto |
Organization
Department of Junior College, Kanagawa Dental University
Division name
School of Dental Hygiene
Zip code
Address
82 Inaoka-Cho, Yokosuka, Kanagawa, Japan
TEL
046-822-8755
Homepage URL
yamamoto.yuko@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental 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
Address
Tel
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
| 2017 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 10 | Day |
Last modified on
| 2017 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032773
