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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026727
Receipt No. R000030686
Scientific Title Double-blind randomized parallel intergroup trial on the efficacy of the Lactobacillus rhamnosus L8020 containing gummi for oral health
Date of disclosure of the study information 2017/03/29
Last modified on 2019/08/02

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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

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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