UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063289 |
|---|---|
| Receipt number | R000072442 |
| Scientific Title | Exploratory Study of a Healthcare Indicator Based on a Simple Fecal Short-Chain Fatty Acid Test |
| Date of disclosure of the study information | 2026/10/22 |
| Last modified on | 2026/10/16 16:44:06 |
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Basic information
Public title
Exploratory Study of a Healthcare Indicator Based on a Simple Fecal Short-Chain Fatty Acid Test
Acronym
Exploratory Study of a Healthcare Indicator Based on a Simple Fecal Short-Chain Fatty Acid Test
Scientific Title
Exploratory Study of a Healthcare Indicator Based on a Simple Fecal Short-Chain Fatty Acid Test
Scientific Title:Acronym
Exploratory Study of a Healthcare Indicator Based on a Simple Fecal Short-Chain Fatty Acid Test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to conduct an integrated analysis of fecal short-chain fatty acid levels, stool characteristics, and various other non-invasively obtainable data to elucidate their associations with abdominal symptoms and blood-based health-related biomarkers. Based on the findings, we will also seek to develop novel healthcare indicators that combine information on short-chain fatty acid levels with other non-invasively obtainable data.
Basic objectives2
Others
Basic objectives -Others
This study is not intended to evaluate any medical efficacy or safety outcomes in the study participants.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study aims to evaluate the associations between fecal short-chain fatty acid levels and stool characteristics, abdominal symptoms, gut microbiota composition, lifestyle factors, and blood-based health-related biomarkers. Furthermore, by integrating and analyzing these data, the study seeks to generate insights that will contribute to the development of novel healthcare indicators based on non-invasively obtainable information, including fecal short-chain fatty acid levels and stool characteristics.
This study is not intended to evaluate any medical efficacy or safety outcomes in the study participants.
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
(1) Male and female participants aged 20 years or older at the time of informed consent.
(2) Individuals who are able to collect stool samples and perform finger-prick blood sampling at home and submit the samples according to the specified procedures.
(3) Individuals who have received a sufficient explanation of the study, are able to understand its contents, and can provide informed consent voluntarily.
Key exclusion criteria
1 Individuals who have or are suspected of having an infectious disease that may be transmitted through stool or blood.
2 Individuals who have taken medications that may affect the study results (e.g., antibiotics, probiotics, or laxatives) within one month prior to stool sample collection.
3 Individuals who have undergone surgical procedures that may affect the study results (e.g., endoscopic colorectal surgery, gallstone removal, cholecystectomy, or gastric bypass surgery) within six months prior to obtaining informed consent.
4 Individuals with a current or past history of liver cancer, ulcerative colitis, Crohn's disease, or Parkinson's disease.
5 Individuals who are otherwise deemed ineligible for participation in the study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metagen,Inc.
Division name
Headquarters
Zip code
9970052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
clinical-trials@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metagen,Inc.
Division name
Headquarters
Zip code
9970052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
clinical-trials@metagen.co.jp
Sponsor or person
Institute
Metagen,Inc.
Institute
Department
Personal name
Funding Source
Organization
Metagen,Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2nd Floor, Daiwa Building, 3-3-10 Nihonbashi-Honishicho, Chuo-ku, Tokyo, Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.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
| 2026 | Year | 10 | Month | 22 | 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
| 2026 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No results are available yet.
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072442
