UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024630 |
|---|---|
| Receipt number | R000028335 |
| Scientific Title | Study of oral health control and probiotics in the elderly people |
| Date of disclosure of the study information | 2016/11/03 |
| Last modified on | 2019/02/26 09:17:44 |
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Basic information
Public title
Study of oral health control and probiotics in the elderly people
Acronym
Oral health and probiotics
Scientific Title
Study of oral health control and probiotics in the elderly people
Scientific Title:Acronym
Oral health and probiotics
Region
| Japan |
Condition
Condition
healthy elderly people
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim is to assess the effect of lactic acid bacteria-containing tablets on oral health control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of oral health condition by the oral administration of lactic acid bacteria-containing tablets for 2 months: Plaque index, tongue coating, probing pocket depth, bleeding on probing, volatile sulfur compound.
Key secondary outcomes
composition of oral microbiota
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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 subjects ingest the tablets containing Lactobacillus salivarius WB21 for 2 months. The dose throughout the test period is maintained at 1 tablet 3 times per day (2.0 x 10^9 colony forming units per day), taken orally after eating and mouth cleaning.
Interventions/Control_2
The subjects ingest the placebo tablets for 2 months. The dose throughout the test period is maintained at 1 tablet 3 times per day, taken orally after eating and mouth cleaning. The placebo tablets are same composition except for L. salivarius WB21.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy elderly people
Key exclusion criteria
not wearing complete denture prostheses, not currently visiting a dentist for treatment, not using antibiotics within 3 months, having no smoking habit, having no adverse reactions to lactose or fermented milk products, having no serious metabolic disorders, having no cancer
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Hirofuji |
Organization
Fukuoka Dental College
Division name
Department of General Dentistry
Zip code
Address
2-15-1, Tamura Sawara-ku, Fukuoka, Japan
TEL
81-91-801-0411
hirofuji@college.fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nao Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of Preventive and Public Health Dentistry
Zip code
Address
2-15-1, Tamura Sawara-ku, Fukuoka, Japan
TEL
81-91-801-0411
Homepage URL
naojsz@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
筑紫南コミュニティセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 03 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028335
