UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058596 |
|---|---|
| Receipt number | R000066903 |
| Scientific Title | Additional testing for [Evaluation of the Effects of a 4-Week Consumption of Oligosaccharides on Bowel Movement Improvement (A)] |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/25 14:13:36 |
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Basic information
Public title
Additional testing for [Evaluation of the Effects of a 4-Week Consumption of Oligosaccharides on Bowel Movement Improvement (A)]
Acronym
Additional testing for [Evaluation of the Effects of a 4-Week Consumption of Oligosaccharides on Bowel Movement Improvement (A)]
Scientific Title
Additional testing for [Evaluation of the Effects of a 4-Week Consumption of Oligosaccharides on Bowel Movement Improvement (A)]
Scientific Title:Acronym
Additional testing for [Evaluation of the Effects of a 4-Week Consumption of Oligosaccharides on Bowel Movement Improvement (A)]
Region
| Japan |
Condition
Condition
N/A (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of yogurt intake on bile acids, immune markers, intestinal barrier function and fecal metabolites, and whether there is a relationship with bowel movements, intestinal flora, blood parameters, etc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
concentration of bile acids, secretory IgA, Calprotectin, mucin, zonulin in feces, and its relationship to existing data.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The Per Protocol Set examined in the other study (UMIN000055373)
Key exclusion criteria
Subjects who declined to provide samples and information for this study during the information disclosure period
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Makino |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
81-42-632-5847
seiya.makino@meiji.com
Public contact
Name of contact person
| 1st name | aiko |
| Middle name | |
| Last name | Ishiguro |
Organization
CPCC Co., Ltd.
Division name
Business management section
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
info@cpcc.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
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
Tel
81-42-632-5900
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 | 08 | Month | 01 | 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 | 07 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted using samples obtained in the other study (UMIN000055373). There is no intervention and invasion in this study.
Management information
Registered date
| 2025 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066903
