UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060164 |
|---|---|
| Receipt number | R000067361 |
| Scientific Title | Evaluation of the effects of tongue cleaning and oil pulling on Gut Microbiota based on the Oral-Gut Axis |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/22 17:38:00 |
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Basic information
Public title
Evaluation of the effects of tongue cleaning and oil pulling on Gut Microbiota based on the Oral-Gut Axis
Acronym
Effects of tongue cleaning and oil pulling on gut microbiota
Scientific Title
Evaluation of the effects of tongue cleaning and oil pulling on Gut Microbiota based on the Oral-Gut Axis
Scientific Title:Acronym
Effects of tongue cleaning and oil pulling on gut microbiota
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether tongue cleaning and oil pulling, as forms of self-oral care, can improve the balance of the gut microbiota in healthy adults through the modulation of the oral microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Gut microbiota composition
Key secondary outcomes
1. Gut microbiota diversity
2. Oral microbiota composition
3. Bowel consistency
4. Bowel movement
5. Oral health-related quality of life (OHRQoL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Tongue cleaning every morning for 3 months
Interventions/Control_2
Oil pulling every morning for 3 months
Interventions/Control_3
Mouthwash every morning for 3 months
Interventions/Control_4
No treatment
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 18 years or older and younger than 65 years
2. Healthy individuals
Key exclusion criteria
1. Individuals who have practiced tongue cleaning, oil pulling, or mouthwash use within the past month
2. Individuals who have taken, within the past month, medications (e.g., antibiotics, immunosuppressants, chemotherapy), probiotics, supplements, or functional foods that affect the gut microbiota
3. Women who are pregnant or breastfeeding
4. Individuals currently undergoing treatment for periodontitis
5. Individuals with sesame oil allergy
6. Individuals with a history of or currently undergoing treatment for malignant neoplasms of the digestive system
7. Any other individuals deemed inappropriate for participation in this study by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Tokinobu |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto City
TEL
075-753-9454
tokinobu.akiko.5c@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Tokinobu |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto City
TEL
075-753-9454
Homepage URL
tokinobu.akiko.5c@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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 | 12 | Month | 22 | 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 | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067361
