UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043171 |
|---|---|
| Receipt number | R000048691 |
| Scientific Title | Changes in the number of Streptococcus mutans after intake of Lactobacillus rhamnosus L8020-containing tablets |
| Date of disclosure of the study information | 2021/01/29 |
| Last modified on | 2022/03/25 14:13:11 |
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Basic information
Public title
Changes in the number of Streptococcus mutans after intake of Lactobacillus rhamnosus L8020-containing tablets
Acronym
Changes in the number of Streptococcus mutans after intake of L8020-containing tablets
Scientific Title
Changes in the number of Streptococcus mutans after intake of Lactobacillus rhamnosus L8020-containing tablets
Scientific Title:Acronym
Changes in the number of Streptococcus mutans after intake of L8020-containing tablets
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in the number of Streptococcus mutans after the intake of tablets containing L8020
Basic objectives2
Others
Basic objectives -Others
To investigate changes in the number of Streptococcus mutans due to differences in the expression of cnm gene
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the distribution of semi-quantitative values of the number of Streptococcus mutans 4 weeks after intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Volunteers ingest one L8020-containing tablet every day after dinner for 4 weeks.
Interventions/Control_2
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy adult without dental caries, gingivitis and periodontal disease
2. Subject who will be able to prohibit other L8020 products during experiment period
3. Subject who provides written informed consents
Key exclusion criteria
1. Subject with allergy to dairy products
2. Subject with a history of antibiotic treatment within a month before experiment
3. Subject who may receive oral treatment of topical fluoride during experiment period
4. Subjects who may be newly treated with povidone-iodine during experiment period
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nikawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Oral Biology & Engineering
Zip code
734-8551
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 | Masae |
| Middle name | |
| Last name | Kitagawa |
Organization
Hiroshima University Hospital
Division name
Center of Oral Clinical Examination
Zip code
731-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5727
Homepage URL
mhiraoka@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Oral Biology & Engineering, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
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
| 2021 | Year | 01 | 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
81
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
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048691
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
