UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039503 |
|---|---|
| Receipt number | R000044383 |
| Scientific Title | Exploratory study on the effects of oral spray containing Lactobacillus rhamnosus L8020 in the oral cavity (compared with tablets containing L8020) |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2021/01/30 17:58:18 |
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Basic information
Public title
Antibacterial effect of oral spray containing L8020 lactic acid bacteria
against oral bacteria
Acronym
Antibacterial effect of oral spray containing L8020 lactic acid bacteria
Scientific Title
Exploratory study on the effects of oral spray containing Lactobacillus rhamnosus L8020 in the oral cavity (compared with tablets containing L8020)
Scientific Title:Acronym
Exploratory study on the effects of oral spray containing L8020
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of oral spray containing L8020 compared with tablets containing L8020.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bad breath (by bad breath measuring instrument)
Key secondary outcomes
Caries risk (by using a simple saliva test kit)
Periodontal disease status (with a simple saliva test kit)
Taste, fragrance, residual feeling (questionnaire survey)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Oral spray administration (60 minutes)
Interventions/Control_2
Tablet administration (60 minutes)
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
Teachers / staff working at Hiroshima University or students attending Hiroshima University
1. Those who are older than 20 years old and older than 70 years old when obtaining consent
2. Person who can obtain consent from the person in writing regarding participation in this research
Key exclusion criteria
1. Those who have dairy allergy
2. Those who have dental illnesses that require dental treatment
3. Persons with diseases that affect bad breath outside the oral cavity (Sjogren's syndrome, sinusitis, other systemic diseases, etc.)
4. Those who have taken L8020-containing products within 3 weeks before registration
5. Participants in other clinical research (including clinical trials)
6. Those who are deemed inappropriate by the person in charge of conducting the research
7. Those who have an interest in the researcher
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nikawa |
Organization
Hiroshima University
Division name
Department of Oral Biology & Engineering, Graduate School of Biomedical & Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi Minami-ku, Hiroshima City, Hiroshima
TEL
082-257-5097
hirocky@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Taji |
Organization
Hiroshima University
Division name
Department of Oral Biology & Engineering, Graduate School of Biomedical & Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi Minami-ku, Hiroshima City, Hiroshima
TEL
082-257-5622
Homepage URL
taji@hiroshima-u.ac.jp
Sponsor or person
Institute
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
Hiroshima university ethics committee
Address
1-2-3 Kasumi Minami-ku, Hiroshima City, Hiroshima
Tel
082-257-1576
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
| 2020 | Year | 02 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044383
