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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020795
Receipt No. R000023672
Scientific Title Colonization of Lactobacillus rhamnosus L8020 in the oral cavity after intake of L8020-containing tablets
Date of disclosure of the study information 2016/01/29
Last modified on 2019/07/29

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Basic information
Public title Colonization of Lactobacillus rhamnosus L8020 in the oral cavity after intake of L8020-containing tablets
Acronym Oral colonization of Lactobacillus rhamnosus L8020
Scientific Title Colonization of Lactobacillus rhamnosus L8020 in the oral cavity after intake of L8020-containing tablets
Scientific Title:Acronym Oral colonization of Lactobacillus rhamnosus L8020
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether Lactobacillus rhamnosus L8020 can be detected in the oral cavity after the intake of tablets containing L8020
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PCR detection for Lactobacillus in stimulated saliva 7 days before and 2, 7 and 14 days after intervention
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 three L8020-containing tablets everyday after lunch for two 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
100 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 foods with lactic acid bacteria, xylitol chewing gum and other tablets during experiment period
3. Subject who provide 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 treatments of topical fluoride or povidone-iodine during experiment period
Target sample size 50

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 Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization
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 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
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 01 Month 29 Day
Date of IRB
2017 Year 03 Month 15 Day
Anticipated trial start date
2016 Year 03 Month 01 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
2018 Year 11 Month 05 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 29 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023672

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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