UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059822 |
|---|---|
| Receipt number | R000068407 |
| Scientific Title | Observational evaluation of the effects of daily use of agarooligosaccharide-containing mouthwash on oral and intestinal microbiota |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/19 10:35:16 |
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Basic information
Public title
Observational evaluation of the effects of daily use of agarooligosaccharide-containing mouthwash on oral and intestinal microbiota
Acronym
Observational evaluation of the effects of daily use of agarooligosaccharide-containing mouthwash on oral and intestinal microbiota
Scientific Title
Observational evaluation of the effects of daily use of agarooligosaccharide-containing mouthwash on oral and intestinal microbiota
Scientific Title:Acronym
Observational evaluation of the effects of daily use of agarooligosaccharide-containing mouthwash on oral and intestinal microbiota
Region
| Japan |
Condition
Condition
digestive diseases or healthy individuals
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe and evaluate the effects of using agarooligosaccharide-containing mouthwash as part of a normal lifestyle on oral and intestinal flora.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes and amounts of changes in oral or intraoral bacteria during intervention with the study food ingredients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Use of agarooligosaccharide-containing mouthwash in daily life
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have given their informed consent to participate in this study.
2. Patients aged 18 and over who visited the Department of Gastroenterology at Fujita Health University Hospital.
3. Healthy individuals aged 18 or older who are faculty, staff, or students at Fujita Health University
Key exclusion criteria
1. Individuals will be excluded if they have taken antibiotics within one week of sample collection or during the study period
(supplements are not specifically excluded).
2. Patients who are deemed inappropriate by a doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Nakano |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
4701192
Address
1-98, Dengakugakubo, Kutsukake- Cho, Toyoake, Aichi
TEL
+81562932324
maruko@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Nakano |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
4701192
Address
1-98, Dengakugakubo, Kutsukake- Cho, Toyoake, Aichi
TEL
+81562932324
Homepage URL
maruko@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake- Cho, Toyoake, Aichi
Tel
+81562932865
f-irb@fujita-hu.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 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068407
