UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026727 |
|---|---|
| Receipt number | R000030686 |
| Scientific Title | Double-blind randomized parallel intergroup trial on the efficacy of the Lactobacillus rhamnosus L8020 containing gummi for oral health |
| Date of disclosure of the study information | 2017/03/29 |
| Last modified on | 2019/08/02 18:05:25 |
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Basic information
Public title
Double-blind randomized parallel intergroup trial on the efficacy of the Lactobacillus rhamnosus L8020 containing gummi for oral health
Acronym
Effect of Lactobacillus rhamnosus L8020 containing gummi on oral health
Scientific Title
Double-blind randomized parallel intergroup trial on the efficacy of the Lactobacillus rhamnosus L8020 containing gummi for oral health
Scientific Title:Acronym
Effect of Lactobacillus rhamnosus L8020 containing gummi on oral health
Region
| Japan |
Condition
Condition
Healthy people
Patient with periodontal disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether Lactobacillus rhamnosus L8020 can affect oral conditon of people after intake of Lactobacillus rhamnosus L8020-containing gummi
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gingival index
Key secondary outcomes
Plaque index
Breath odor
Caries risk
Periodontal status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Volunteers ingest the L8020-containing gummi everyday for three months
Interventions/Control_2
Volunteers ingest the placebo gummi everyday for three months
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
Company staff member of MITSUI & CO., LTD. who receive dental checkups
Key exclusion criteria
1. Subject with allergy to dairy products
2. Subject who receive dental treatments
3. Subject with desease effecting breath odor (Sjogren syndrome, Sinus inflammation, Systemic illness etc.)
4. Subject who intake L8020 containing products
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nikawa Hiroki |
Organization
Hiroshima University
Division name
Department of Oral Biology & Engineering
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5097
hirocky@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nikawa Hiroki |
Organization
Hiroshima University
Division name
Department of Oral Biology & Engineering
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5097
Homepage URL
hirocky@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
| 2017 | Year | 03 | 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
| 2017 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 29 | 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
| 2017 | Year | 03 | Month | 27 | 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=R000030686
