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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039070
Receipt No. 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 2020/07/08

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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
Email 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
Email h-kosaka@fujicco.co.jp

Sponsor
Institute Fujicco Co., Ltd.
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044561

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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