UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060424 |
|---|---|
| Receipt number | R000069127 |
| Scientific Title | The effect of mouthwash containing agaro-oligosaccharides on the composition and diversity of the oral microbiome |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/21 15:19:11 |
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Basic information
Public title
The effect of mouthwash containing agaro-oligosaccharides on the composition and diversity of the oral microbiome
Acronym
The effect of mouthwash containing agaro-oligosaccharides on the composition and diversity of the oral microbiome
Scientific Title
The effect of mouthwash containing agaro-oligosaccharides on the composition and diversity of the oral microbiome
Scientific Title:Acronym
The effect of mouthwash containing agaro-oligosaccharides on the composition and diversity of the oral microbiome
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effects of using a mouthwash containing agaro-oligosaccharides for two weeks on the oral microbiome in healthy individuals. Furthermore, by evaluating clinical and biochemical parameters as secondary endpoints, we will explore the overall effects on the oral environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral microbiome
Key secondary outcomes
Subjective symptoms reported by participants (swelling, bleeding, halitosis; assessed via questionnaire), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), Bleeding on Probing (BOP), Plaque Index (PI), Gingival status around implants (Gingival Index: GI), Fecal microbiome, Measurement of Colony Forming Units (CFU), Salivary mucin levels
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
Participants gargle with 15 mL of Test Solution A twice daily (after waking up and before bedtime) for at least 30 seconds for a period of 2 weeks. Following a 1-week washout period, they gargle with the other test solution for 2 weeks under the same conditions (15 mL per dose, twice daily, for at least 30 seconds).
Interventions/Control_2
Participants gargle with 15 mL of Test Solution B twice daily (after waking up and before bedtime) for at least 30 seconds for a period of 2 weeks. Following a 1-week washout period, they gargle with the other test solution for 2 weeks under the same conditions (15 mL per dose, twice daily, for at least 30 seconds).
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate
2.Persons who are Japanese citizens, aged 20 or older and under 65 at the time of consent
Key exclusion criteria
1.Persons who have systemic diseases (such as severe heart disease, renal disease, or hepatic dysfunction) and are receiving medical treatment, or those with a history of such diseases.
2.Persons who have severe oral diseases (such as stomatitis or advanced dental caries) that are judged by the investigator as likely to affect the study outcomes.
3.Persons who have a history of using antibiotics, steroids, or anti-inflammatory drugs within one week prior to saliva collection.
4.Persons who regularly use medications or Food with Health Claims (including Food for Specified Health Uses (FOSHU), Food with Function Claims, and Food with Nutrient Function Claims) that may affect the oral environment.
5.Persons who are at risk of developing allergies related to the test foods
6.Persons who regularly use the test solution on a routine basis.
7.Persons who are judged unsuitable as research subjects based on their responses to a background survey
8.Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research.
9.Persons who are breastfeeding, pregnant, or have plans to become pregnant during the study period
10.Persons who are judged to be ineligible by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
BIOSIS Lab. Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ina Food Industry Co., 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 01 | 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
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 | 12 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069127
