UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of oral health control and probiotics in the elderly people
Title of the study (Brief title)	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	Takao Hirofuji
Organization	Fukuoka Dental College
Division name	Department of General Dentistry
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	Nao Taniguchi
Organization	Fukuoka Dental College
Division name	Department of Preventive and Public Health Dentistry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028335