UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053163 |
|---|---|
| Receipt number | R000060659 |
| Scientific Title | Analytical observational study examining the effects of exercise on the oral and intestinal microbiome and its impact on systemic health in adults |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/01/30 18:47:31 |
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Basic information
Public title
Effect of exercise on the oral microbiome and its systemic implications
Acronym
Effect of exercise on the oral microbiome and its systemic implications
Scientific Title
Analytical observational study examining the effects of exercise on the oral and intestinal microbiome and its impact on systemic health in adults
Scientific Title:Acronym
Effect of exercise on the oral microbiome and its impact on systemic health
Region
| Japan |
Condition
Condition
Periodontal disease
Healthy adult
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effects of exercise on the oral and intestinal microbiome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial composition of oral and intestinal microbiome before and after exercise, and with and without exercise habits.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Meles and females aged 18 or older, and 65 under at the time of obtaining consent.
Subjects who have been fully informed of the purpose and content of this study, who are competent to give informed consent, who voluntarily and intelligently agree to participate, and who provide written consent to participate in this study.
Key exclusion criteria
Subjects with a history of serious systemic disease (liver, renal, cardiovascular, cerebrovascular, respiratory, etc.) and with exercise limitations
Subjects who have received systemic or local antibiotics within the past 3 months
Subjects with infectious diseases such as HBV, HCV, and HIV
Subjects with extremely irregular daily routines and eating habits
Subjects who are pregnant, nursing, or potentially pregnant women
Subjects who are judged ineligible by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Takeuchi |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Lifetime Oral Health Care Science, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4970
takeuchi.peri@tmd.aac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Takeuchi |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Lifetime Oral Health Care Science, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549
TEL
03-5803-4970
Homepage URL
takeuchi.peri@tmd.aac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Tokyo Medical and Dental University (TMDU)
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5404
d-hyoka.adm@tmd.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
東京医科歯科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
| 2023 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | 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
We will compare the characteristics of oral and intestinal microbiome before and after exercise and exercise habits.
The influence of the exercise load, stress hormones, and diet on the microbiome will also be studied.
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060659
