UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059184 |
|---|---|
| Receipt number | R000067698 |
| Scientific Title | A prospective cohort study on the association between intestinal barrier function and disease onset |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/09/25 15:20:26 |
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Basic information
Public title
A study on the association between intestinal barrier function and disease onset
Acronym
A study on the association between intestinal barrier function and disease onset
Scientific Title
A prospective cohort study on the association between intestinal barrier function and disease onset
Scientific Title:Acronym
A prospective cohort study on the association between intestinal barrier function and disease onset
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to investigate which diseases are associated with the status of intestinal barrier function using large-scale community-based cohort data.
Basic objectives2
Others
Basic objectives -Others
The primary objective is to investigate which diseases are associated with the status of intestinal barrier function using large-scale community-based cohort data.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the association between intestinal barrier markers and disease onset in cohort data.
Key secondary outcomes
To investigate the association between intestinal barrier markers and disease onset, incorporating metabolomic analysis data.
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
| 45 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants in the Tohoku Medical Megabank Project cohort study who took part in both the baseline survey and the second survey, with the baseline survey being the community-based cohort.
Key exclusion criteria
1. Participants who requested to opt out of providing samples or information for this study during the information disclosure period.
2. Participants with a history of irritable bowel syndrome, ulcerative colitis, Crohn's disease, or colorectal cancer at the time of the baseline survey.
3. Participants who had taken within the previous two weeks antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), gastroprotective agents, metformin, immunosuppressants, or other medications reported to affect intestinal barrier function.
4. Participants deemed unsuitable as participants by the principal investigator.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Sashihara |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
1920919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5842
toshihiro.sashihara@meiji.com
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Katsukura |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
1920919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5842
Homepage URL
yuka.katsukura@meiji.com
Sponsor or person
Institute
Meiji Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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 | 09 | 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
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
| 2025 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective cohort study investigates the association between intestinal barrier function and disease onset, using large-scale community-based cohort data from the Tohoku Medical Megabank Organization.
Management information
Registered date
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067698
