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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024630
Receipt No. 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

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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
Email 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
Email naojsz@college.fdcnet.ac.jp

Sponsor
Institute Fukuoka Dental College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028335

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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