UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052411 |
|---|---|
| Receipt number | R000059827 |
| Scientific Title | Search for new biomarkers using disease patient samples |
| Date of disclosure of the study information | 2023/10/15 |
| Last modified on | 2023/11/14 09:16:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Search for new biomarkers using disease patient samples
Acronym
Search for new biomarkers using disease patient samples
Scientific Title
Search for new biomarkers using disease patient samples
Scientific Title:Acronym
Search for new biomarkers using disease patient samples
Region
| Japan |
Condition
Condition
Crohn's disease patient, IBS patient, Healthy subjects
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Search for new biomarkers associated with Crohn's disease and IBS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To search for new biomarkers specific to Crohn's disease and IBS, based on the results of comprehensive metabolite analysis obtained from the samples in this study.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women who are between 20 and 75 years old at the time of sample submission
2. Subjects who provided samples to the NCGM Biobank and met the selection criteria for each group listed below
Crohn's disease patient group: Subjects diagnosed with Crohn's disease
IBS patient group: Subjects diagnosed with IBS
Healthy group: Subjects who meet the following conditions
- No notable chronic diseases
- No oral medications (including herbal medicines and supplements)
- No abnormal values found in general blood test items
Key exclusion criteria
1. Subjects who have a smoking habit
2. Subjects whose infectious disease test (HBs antigen, HCV antibody, HIV antigen/antibody, etc.) was positive
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Ichihara |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
1920919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5838
yoshitatsu.ichihara@meiji.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Morifuji |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
1920919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5838
Homepage URL
masashi.morifuji@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine, IRB
Address
1-21-1 Toyama, Shinjuku, Tokyo, Japan
Tel
03-3202-7181
rinri@hosp.ncgm.go.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
| 2023 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059827
