UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023503 |
|---|---|
| Receipt number | 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 | 2019/08/02 18:00:37 |
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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
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
taji@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Oral Biology & Engineering,
Integrated Health Sciences, Institute of
Biomedical and Health Sciences, Hiroshima
University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 14 | 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
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027070
