UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051426 |
|---|---|
| Receipt number | R000058665 |
| Scientific Title | Verification and identification of new biomarkers for intestinal barrier function |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2024/03/22 15:53:50 |
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Basic information
Public title
Verification and identification of new biomarkers for intestinal barrier function
Acronym
Verification and identification of new biomarkers for intestinal barrier function
Scientific Title
Verification and identification of new biomarkers for intestinal barrier function
Scientific Title:Acronym
Verification and identification of new biomarkers for intestinal barrier function
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the efficacy of biomarkers discovered in previous studies and identification for new biomarkers
Basic objectives2
Others
Basic objectives -Others
Verification of the efficacy of biomarkers discovered in previous studies and identification for new biomarkers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verification of the efficacy of biomarkers discovered in previous studies. Identification for new biomarkers from this study.
Key secondary outcomes
Investigation of changes in biomarkers with yogurt intake.
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. Subjects underwent a pre-ingestion test among the study subjects in the study in which the specimen was obtained
2. Subjects who did not request withdrawal from participation in this study
Key exclusion criteria
1. Subjects whose samples (plasma, urine, stool) have not been obtained at all
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Morifuji |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
81-42-632-5838
masashi.morifuji@meiji.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
81-3-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Gokan-machi, Maebashi-shi, Gunma, Japan
Tel
027-261-7600
info@kobunaseikei.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 | 06 | Month | 23 | 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
149
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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
untargeted metabolomics
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058665
