UMIN-CTR Clinical Trial

Basic information
Public title	Double-blind randomized parallel intergroup trial on the efficacy of the Lactobacillus rhamnosus L8020 containing gummi for oral health
Acronym	Effect of Lactobacillus rhamnosus L8020 containing gummi on oral health
Scientific Title	Double-blind randomized parallel intergroup trial on the efficacy of the Lactobacillus rhamnosus L8020 containing gummi for oral health
Scientific Title:Acronym	Effect of Lactobacillus rhamnosus L8020 containing gummi on oral health
Region	Japan

Condition
Condition	Healthy people Patient with periodontal disease
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether Lactobacillus rhamnosus L8020 can affect oral conditon of people after intake of Lactobacillus rhamnosus L8020-containing gummi
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gingival index
Key secondary outcomes	Plaque index Breath odor Caries risk Periodontal status

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Volunteers ingest the L8020-containing gummi everyday for three months
Interventions/Control_2	Volunteers ingest the placebo gummi everyday for three months
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Company staff member of MITSUI & CO., LTD. who receive dental checkups
Key exclusion criteria	1. Subject with allergy to dairy products 2. Subject who receive dental treatments 3. Subject with desease effecting breath odor (Sjogren syndrome, Sinus inflammation, Systemic illness etc.) 4. Subject who intake L8020 containing products
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nikawa Hiroki
Organization	Hiroshima University
Division name	Department of Oral Biology & Engineering
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5097
Email	hirocky@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Nikawa Hiroki
Organization	Hiroshima University
Division name	Department of Oral Biology & Engineering
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5097
Homepage URL
Email	hirocky@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 29 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	2017 Year 03 Month 29 Day
Date of IRB	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 29 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 27 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030686