UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062631 |
|---|---|
| Receipt number | R000071690 |
| Scientific Title | A study to evaluate the efficacy of tablets containing lactic acid bacteria in improving the oral environment -A randomized, double-blind, placebo-controlled study- |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/20 11:42:03 |
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Basic information
Public title
A study to evaluate the efficacy of tablets containing lactic acid bacteria in improving the oral environment
Acronym
A study to evaluate the efficacy of tablets containing lactic acid bacteria in improving the oral environment
Scientific Title
A study to evaluate the efficacy of tablets containing lactic acid bacteria in improving the oral environment
-A randomized, double-blind, placebo-controlled study-
Scientific Title:Acronym
A study to evaluate the efficacy of tablets containing lactic acid bacteria in improving the oral environment
-A randomized, double-blind, placebo-controlled study-
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of the intake of test food on the oral environment. In addition, the effects of different intake levels will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of a specific oral bacterium and its proportion relative to the total bacterial count
Key secondary outcomes
*Secondary evaluation items
1) Gingival Index
2) Plaque Index
3) Bleeding on probing
4) Probing depth
5) Total bacterial count
*Safety evaluation items
1) Medical interview, including subjective and objective symptoms
2) Dental status
3) Oral mucosa
4) Tooth staining
5) Stimulated saliva volume
6) Stimulated salivary pH
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 tablet a day) for 4 weeks (intake level 1).
Interventions/Control_2
Consumption of the test food (1 tablet a day) for 4 weeks (intake level 2).
Interventions/Control_3
Consumption of the placebo food (1 tablet a day) for 4 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20 years or older but under 65 years at the time of obtaining informed consent to participate in the study.
2) Individuals with mild to moderate gingivitis or periodontitis.
3) Individuals who have not undergone dental procedures, such as scaling or professional dental cleaning, that may affect the oral environment at the assessment sites within the past year.
4) Individuals in whom at least four of the six index teeth used for oral examinations can be assessed, or who have substitute teeth specified in the study protocol.
5) Individuals who are not currently receiving treatment for dental caries or periodontal disease and who have at least 20 teeth.
6) Individuals who have received sufficient explanation regarding the purpose and content of this study, possess the capacity to provide consent, voluntarily agree to participate after fully understanding the study, and can provide written informed consent to participate in this study.
Key exclusion criteria
1) Individuals judged at the screening examination to have dental caries classified as C3 or higher, or severe periodontal disease.
2) Individuals who have diabetes mellitus, chronic kidney disease, gastrointestinal disorders, pulmonary disease, malignant tumors, or other relevant diseases and are taking medication for these conditions.
3) Individuals with systemic diseases that make participation in the study difficult.
4) Individuals who are currently taking antibiotics or antimicrobial agents, or who have taken such agents within one month before the screening examination.
5) Individuals who are unable to discontinue, during the study period, the use or consumption of dental professional products or dentifrices that may affect the study results; foods containing lactic acid bacteria, bifidobacteria, or oligosaccharides; or supplements or health foods, including Foods for Specified Health Uses and Foods with Function Claims, that may affect oral hygiene.
6) Individuals who use products intended to prevent periodontal disease, such as interdental brushes or dental floss.
7) Individuals who are pregnant or lactating, or who intend to become pregnant during the study period.
8) Individuals who are currently participating in another study involving a drug or food, or who intend to participate in another such study.
9) Individuals whose stimulated saliva volume over 5 minutes is 3.0 mL or less, or who have been diagnosed with dry mouth.
10) Individuals whose stimulated salivary pH is 6.2 or lower.
11) Individuals with food allergies.
12) Individuals who wear removable dentures or have implants in the teeth designated for oral examination.
13) Individuals who are currently undergoing orthodontic treatment.
14) Smokers.
15) Individuals who plan to travel overseas for personal or business purposes during the study period.
16) Individuals deemed unsuitable for participation in this study by the principal investigator.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Misaki |
| Middle name | |
| Last name | Hatanaka |
Organization
Asahi Group Foods, Ltd.
Division name
R&D Division, Technology Development Department 1
Zip code
302-0106
Address
1-1-21 Midori, Moriya-shi, Ibaraki, Japan
TEL
0297-46-4105
misaki.hatanaka@asahi-gf.co.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Nakayama |
Organization
Asahi Group Foods, Ltd.
Division name
R&D Division, Technology Development Department 1
Zip code
302-0106
Address
1-1-21 Midori, Moriya-shi, Ibaraki, Japan
TEL
070-3187-3946
Homepage URL
yasunori.nakayama@asahi-gf.co.jp
Sponsor or person
Institute
Asahi Group Foods, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi, Maebashi-shi, Gumma, Japan
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2026 | Year | 08 | Month | 21 | 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
45
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
| 2026 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071690
