UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057122 |
|---|---|
| Receipt number | R000065289 |
| Scientific Title | Analysis of lifestyle factors and gut microbiota related to intestinal symptoms |
| Date of disclosure of the study information | 2025/02/25 |
| Last modified on | 2025/02/25 01:28:03 |
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Basic information
Public title
GUT Frailty Questionnaire
Acronym
GUT Frailty Questionnaire
Scientific Title
Analysis of lifestyle factors and gut microbiota related to intestinal symptoms
Scientific Title:Acronym
GUT Frailty Questionnaire
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Implementation and analysis of the gut frailty questionnaire
Basic objectives2
Others
Basic objectives -Others
Implementation and analysis of the gut frailty questionnaire
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will analyze the correlation between various intestinal symptoms and lifestyle background factors (diet, exercise, sleep habits), labor productivity, QOL, etc., based on the results of a web-based questionnaire survey. In addition, we will conduct intestinal flora metagenome analysis for those participants who wish to participate, and analyze the correlation between intestinal flora analysis and these intestinal symptom factors and lifestyle background factors.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy individuals aged 20 or over
Key exclusion criteria
Those who have difficulty filling in questionnaires
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Human Immunology and Nutrition Science
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5308
Homepage URL
takatomo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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 | 02 | Month | 25 | 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
3000
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study based on questionnaire survey
Management information
Registered date
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065289
