UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027393 |
|---|---|
| Receipt number | R000031394 |
| Scientific Title | Effects of the yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the IgA flow rate of saliva in elderly persons residing in a nursing home |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2017/05/18 20:43:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of the yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the IgA flow rate of saliva in elderly persons residing in a nursing home
Acronym
Effects of the yogurt on the IgA flow rate of saliva in elderly persons.
Scientific Title
Effects of the yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the IgA flow rate of saliva in elderly persons residing in a nursing home
Scientific Title:Acronym
Effects of the yogurt on the IgA flow rate of saliva in elderly persons.
Region
| Japan |
Condition
Condition
upper respiratory tract infection
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify whether the yogurt fermented with L. bulgaricus OLL1073R-1 intake increases the IgA level in saliva of the elderly person
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IgA flow rate of saliva
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The participants ingested 112 g of the yogurt fermented with L. bulgaricus OLL1073R-1 each day in the morning (10:00 a.m. to 10:30 a.m.) for 12 weeks.Saliva samples were obtained in the morning (9:30 to 10:30 a.m.) before (0 weeks) and after 4, 8, and 12 weeks of the yogurt intake.
Interventions/Control_2
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
The elderly persons who are entering the same special elderly nursing home
Key exclusion criteria
Individuals taking antibiotics or morphine, with gastric fistulae, who disliked yogurt
Target sample size
40
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-Cho, Yokosuka, Kanagawa, 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
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
寒川ホーム
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2013 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2017 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031394
