UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055236 |
|---|---|
| Receipt number | R000063111 |
| Scientific Title | A Research on Gut Microbiota through Onsen Bathing Related to Beppu ONSEN Academia |
| Date of disclosure of the study information | 2024/08/14 |
| Last modified on | 2024/08/15 03:26:06 |
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Basic information
Public title
A Research on Gut Microbiota through Onsen Bathing Related to Beppu ONSEN Academia
Acronym
A Research on Gut Microbiota through Onsen Bathing Related to Beppu ONSEN Academia
Scientific Title
A Research on Gut Microbiota through Onsen Bathing Related to Beppu ONSEN Academia
Scientific Title:Acronym
A Research on Gut Microbiota through Onsen Bathing Related to Beppu ONSEN Academia
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of seven consecutive days of onsen bathing on the metabolic substances of the gut microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in concentration of fecal metabolites (short-chain fatty acids)
Key secondary outcomes
Subjective evaluation questionnaire (defecation, quality of life, physical conditions)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Daily onsen bathing for 7 Days > Wash out for 14 Days > 7 Days without onsen bathing
Interventions/Control_2
7 Days without Onsen bathing > Wash out for 14 Days > Daily Onsen bathing for 7 Days
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
Recruitment Targeting Beppu City Hall Employees and Residents in the Vicinity of Beppu City
1) who have provided written consent voluntarily.
2) aged 18 and above but below 65 at the time of consent acquisition, regardless of gender.
3) who have not been diagnosed with chronic illnesses.
4) who have not bathed in hot springs in the 14 days prior to assignment.
- Artificial hot springs are also considered as hot spring bathing and are excluded.
- Bathing with ordinary tap water is not exempted.
Key exclusion criteria
1) Individuals with a history of hypersensitivity to hot springs.
2) who have taken medication (such as antibiotics, intestinal regulators, laxatives, etc.) that may affect the test one month before the pre-examination, or those who plan to take such medication during the test period.
3) with a history of appendix removal.
4) who have undergone surgery in the six months prior to obtaining consent, which is considered to have an impact on the test (such as colonoscopy, gallstone or gallbladder removal, gastric bypass surgery, etc.).
5) who are expected to undergo significant changes in their living environment, such as moving or job relocation, during the test period.
6) with an extremely irregular dietary lifestyle.
7) Heavy alcohol drinkers.
8) with a history of and current serious illnesses in the heart, liver, kidneys, digestive system, etc.
9) who are pregnant, breastfeeding, or have the intention to become pregnant during the test period.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Managi |
| Middle name | |
| Last name | Shunsuke |
Organization
Kyushu University
Division name
Urban Institute
Zip code
819-0395
Address
#1036 West2, 744 Motooka, Nishi-ku, Fukuoka-Shi, Fukuoka
TEL
092-802-3401
managi.s@gmail.com
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Takeda |
Organization
Kyushu University
Division name
Urban Institute
Zip code
819-0395
Address
#1036 West2, 744 Motooka, Nishi-ku, Fukuoka-Shi, Fukuoka
TEL
092-802-3401
Homepage URL
takeda.midori.102@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Shunsuke Managi
Funding Source
Organization
Beppu City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Urban Institute Research Ethics Committee
Address
#1036 West2, 744 Motooka, Nishi-ku, Fukuoka-Shi, Fukuoka
Tel
092-802-3401
takeda.midori.102@m.kyushu-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
| 2024 | Year | 08 | Month | 14 | 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
16
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 | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2024 | Year | 08 | Month | 13 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063111
