UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051983 |
|---|---|
| Receipt number | R000059276 |
| Scientific Title | Research study on the oral health status of healthy individuals during the oral maintenance phase and the impact of lactobacilli consumption. |
| Date of disclosure of the study information | 2023/08/23 |
| Last modified on | 2025/02/21 15:33:50 |
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Basic information
Public title
Research study on the oral health status of healthy individuals during the oral maintenance phase and the impact of lactobacilli consumption.
Acronym
Research study on the oral health status of healthy individuals and the impact of lactobacilli consumption.
Scientific Title
Research study on the oral health status of healthy individuals during the oral maintenance phase and the impact of lactobacilli consumption.
Scientific Title:Acronym
Research study on the oral health status of healthy individuals and the impact of lactobacilli consumption.
Region
| Japan |
Condition
Condition
male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of lactobacilli consumption on salivary flow rate and other parameters in healthy individuals during the oral maintenance phase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary flow rate
Key secondary outcomes
Periodontal tissue examination (BOP), Assessment of oral dryness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food containing active ingredients
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who have provided written consent for participation in the study.
2) Subjects who are males or females and are aged 20 or older.
Key exclusion criteria
(1) Subjects who are pregnant, of childbearing potential, or intend to conceive during the study period.
(2) Subjects who are nursing.
(3) Subjects with a history of severe diseases.
(4) Subjects undergoing treatment for oral diseases.
(5) Subjects with urgent medical diseases.
(6) Subjects who are regular users of mouthwash or gargle.
(7) Any other individuals considered inappropriate as participants by the principal investigator and principal research scientist.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Neutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13, Saigawa, Otsu, Shiga, Japan
TEL
+81-775-21-8835
Saito.Hiroshi@otsuka.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Neutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13, Saigawa, Otsu, Shiga, Japan
TEL
+81-775-21-8835
Homepage URL
Saito.Hiroshi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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 Research Ethics Committee of Otsuka Pharmaceutical Co., Ltd
Address
3-31-13 Saigawa, Otsu, Shiga
Tel
+81-775-21-8835
Ikenaga.Takeshi@otsuka.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
| 2023 | Year | 08 | Month | 23 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2023 | Year | 08 | Month | 23 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059276
