UMIN-CTR Clinical Trial

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
Email	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
Email	taji@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044383