UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058770 |
|---|---|
| Receipt number | R000067196 |
| Scientific Title | Examination of the effect of food containing Lactobacillus salivarius WB21 on oral Candida species (Randomized, placebo-controlled, double-blind, parallel-group comparative study) |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/08/12 15:22:04 |
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Basic information
Public title
Examination of the effect of food containing WB21 on oral Candida species (Randomized, placebo-controlled, double-blind, parallel-group comparative study)
Acronym
Effect of WB21-containing tablets on oral Candida (RCT)
Scientific Title
Examination of the effect of food containing Lactobacillus salivarius WB21 on oral Candida species (Randomized, placebo-controlled, double-blind, parallel-group comparative study)
Scientific Title:Acronym
Effect of Lactobacillus salivarius WB21-containing tablets on oral Candida (RCT)
Region
| Japan |
Condition
Condition
oral candidiasis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent oral candidiasis, a randomized controlled trial will be conducted to clarify whether the continuous intake of food containing Lactobacillus salivarius WB21 (WB21), a lactic acid bacterium that has been confirmed to inhibit the growth of Candida albicans in in vitro studies, inhibits the growth of Candida in the oral cavity of elderly people who harbor Candida in their mouths, and thus prevents the onset of oral candidiasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of Candida species in the mouth
Key secondary outcomes
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
Study participants will be asked to take "Avambees Oral Tablets" (Wakamoto Pharmaceutical Co., Ltd.), a food containing Lactobacillus salivarius WB21, three times a day for two weeks.
Interventions/Control_2
Study participants will take placebo tablets (Wakamoto Pharmaceutical Co., Ltd.) containing no Lactobacillus salivarius WB21 three times a day for two weeks.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of a certain nursing home in Fukuoka City who has been found to have Candida in his or her oral cavity
Key exclusion criteria
Those who are already using food containing WB21 / Those taking antibiotics / Those with a history of milk allergy or food allergy to food ingredients / Those who the researcher judges to be inappropriate as study participants
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of Preventive and Public Health Dentistry
Zip code
8140175
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
TEL
81-92-801-0616
naojsz@fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of Preventive and Public Health Dentistry
Zip code
8140175
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
TEL
81-92-801-0616
Homepage URL
naojsz@fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Dental College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Gakuen Ethics Committee
Address
2-15-1, Tamura, Sawara-ku, Fukuoka, Japan
Tel
81-92-801-0425
shomu@fdcnet.ac.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
| 2025 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067196
