UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051619 |
|---|---|
| Receipt number | R000058900 |
| Scientific Title | Analytical research of abdominal symptoms and gut environment in athletes |
| Date of disclosure of the study information | 2023/07/15 |
| Last modified on | 2023/07/25 10:55:36 |
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Basic information
Public title
Analytical research of abdominal symptoms and gut environment in athletes
Acronym
Analytical research of abdominal symptoms and gut environment in athletes
Scientific Title
Analytical research of abdominal symptoms and gut environment in athletes
Scientific Title:Acronym
Analytical research of abdominal symptoms and gut environment in athletes
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate the relationship between the presence of abdominal symptoms and the gut environment in athletes.
Basic objectives2
Others
Basic objectives -Others
Relevance
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal barrier index
Key secondary outcomes
Blood test (biochemistry, inflammation, etc.)
Fecal test (microbiota analysis)
Autonomic nervous system index
Evaluation by questionnaire on physical condition
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Students who belong or don't belong to athletic clubs in Juntendo University
Key exclusion criteria
/ Subjects who have diseases that interfere with the research.
/ Subjects who declare themselves unwell on the day of the experiment.
/ Others who have been determined ineligible by the principal investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ko |
| Middle name | |
| Last name | Yamanaka |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-Gakuendai, Inzai, Chiba
TEL
0476-98-1001
k-yamana@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Yamanaka |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-Gakuendai, Inzai, Chiba
TEL
0476-98-1001
Homepage URL
k-yamana@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Metagen, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, Faculty of Health and Sports Science, Juntendo University
Address
1-1 Hiraka-Gakuendai, Inzai, Chiba
Tel
0476-98-1001
sc-rinri@juntendo.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
順天堂大学（千葉県）、Juntendo University(Chiba)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 15 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It has been reported that intestinal barrier function is impaired and abdominal symptoms occur more frequently in athletes. Thus we will conduct case-control sampling of athletes with the aim of examining the relationship between the abdominal symptom and the intestinal environment.
Management information
Registered date
| 2023 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058900
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
