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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023503
Receipt No. R000027070
Scientific Title Effect of intake of tablets or yogurt containing Lactobacillus rhamnosus L8020 on oral bacteria of children and disabilities
Date of disclosure of the study information 2016/08/05
Last modified on 2016/10/20

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Basic information
Public title Effect of intake of tablets or yogurt containing Lactobacillus rhamnosus L8020 on oral bacteria of children and disabilities
Acronym Effect of Lactobacillus rhamnosus L8020 on oral bacteria
Scientific Title Effect of intake of tablets or yogurt containing Lactobacillus rhamnosus L8020 on oral bacteria of children and disabilities
Scientific Title:Acronym Effect of Lactobacillus rhamnosus L8020 on oral bacteria
Region
Japan

Condition
Condition Dental Caries
Gingivitis, Periodontitis
Classification by specialty
Dental medicine Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effect of tblet or yogurt containing Lactobacillus rhamnosus L8020 reduce or suppress oral carriage of cariogenic bacteria, gingivitis, periodontitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral carriage of mutans streptococci
Gingival Index
Key secondary outcomes Oral status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Volunteers ingest tablets-containing L8020 everyday after lunch for one month
Interventions/Control_2 Volunteers ingest yogurt-containing L8020 everyday after lunch for one month
Interventions/Control_3 Volunteers ingest yogurt-placebo everyday after lunch for one month
Interventions/Control_4 Volunteers ingest yogurt-containing L8020 everyday after breakfast for three month
Interventions/Control_5 Volunteers ingest yogurt-containing L8020 everyday after breakfast for three month
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
4 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Subject and parents of guardian who provide written informed consents
Key exclusion criteria 1. Subject with allergy against dairy products or milk
2. Subject with a history of antibiotic treatment within a month before experiment
3. Subject who may receive treatments of topical fluoride or povidone-iodine during experiment period
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Nikawa
Organization Integrated Health Sciences, Institute of
Biomedical and Health Sciences, Hiroshima
University
Division name Department of Oral Biology & Engineering
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5797
Email hirocky@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Taji
Organization Integrated Health Sciences, Institute of Biomedical and Health Sciences, Hiroshima University
Division name Department of Oral Biology & Engineering
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5797
Homepage URL
Email taji@hiroshima-u.ac.jp

Sponsor
Institute Department of Oral Biology & Engineering,
Integrated Health Sciences, Institute of
Biomedical and Health Sciences, Hiroshima
University
Institute
Department

Funding Source
Organization Self-procurement
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
2016 Year 08 Month 05 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 Preinitiation
Date of protocol fixation
2016 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 05 Day
Last modified on
2016 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027070

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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