UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039070 |
|---|---|
| Receipt number | R000044561 |
| Scientific Title | Double-blind and placebo-controlled crossover trial on the efficacy of tablets containing Lactobacillus rhamnosus L8020 for oral condition |
| Date of disclosure of the study information | 2020/01/08 |
| Last modified on | 2023/01/10 09:25:56 |
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Basic information
Public title
Double-blind and placebo-controlled crossover trial on the efficacy of tablets containing Lactobacillus rhamnosus L8020 for oral condition
Acronym
Effect of tablets containing Lactobacillus rhamnosus L8020 on oral condition
Scientific Title
Double-blind and placebo-controlled crossover trial on the efficacy of tablets containing Lactobacillus rhamnosus L8020 for oral condition
Scientific Title:Acronym
Effect of tablets containing Lactobacillus rhamnosus L8020 on oral condition
Region
| Japan |
Condition
Condition
Oral condition
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate influence of oral conditions for those who take tablets containing Lactobacillus rhamnosus L8020
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numbers of bacteria and their microflora analysis in oral plaque
Oral condition (GI, PPD, BOP)
Key secondary outcomes
Salivary test
Breath odor
Experience and feeling effects in body
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Administration of one tablet containig the L8020 every day after lunch for one month
Interventions/Control_2
Administration of one placebo tablet without the L8020 every day after lunch for one month
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healty adults who belonging to Hyogo Prefecture Health Promotion Association, also who can receive dental checkups
2. Aged more that 30 less than 70 years old
3. Subjects who obtain written consent from themselves
4. Subjects whose have own 20 teeth or more
Key exclusion criteria
1. Subjects who are scheduled to receive dental treatment (except for treatment without oral hygiene) during the study period
2. Smokers
3. Subjects in pregnancy
4. Subjects who regularly use antibiotics
5. Subjects with diseases affecting breath odor (Sjogren's syndrome, sinusitis, other systemic diseases, etc.)
6. Subjects with oral implants
7. Subjects with dentures (4 or more teeth on one side)
8. Participants in other clinical studies (including clinical trials)
9. Subjects who are considered unsuitable for this study by the investigator
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Suzuki |
Organization
Fujicco Co., Ltd.
Division name
Research and Development Department
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Japan
TEL
078-303-5385
t-suzuki@fujicco.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kosaka |
Organization
Fujicco Co., Ltd.
Division name
Research and Development Department
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Japan
TEL
078-303-5385
Homepage URL
h-kosaka@fujicco.co.jp
Sponsor or person
Institute
Fujicco Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fujicco Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroshima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa, Osaka, Japan
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
兵庫県健康財団（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 08 | 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
22
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
| 2019 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 01 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044561
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| Registered date | File name |
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