UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054648 |
|---|---|
| Receipt number | R000062383 |
| Scientific Title | Study on the effects of the test compound on the intestinal environment. |
| Date of disclosure of the study information | 2024/06/13 |
| Last modified on | 2024/12/23 14:15:43 |
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Basic information
Public title
Study on the effects of the test compound on the intestinal environment.
Acronym
Study on the effects of the test compound on the intestinal environment.
Scientific Title
Study on the effects of the test compound on the intestinal environment.
Scientific Title:Acronym
Study on the effects of the test compound on the intestinal environment.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test compounds ingestion on the intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microbiota in feces
Key secondary outcomes
Short-chain fatty acid content in feces
Frequency of defecation
Days of defecation
Fecal properties
pH in feces
Survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test compounds for 2 weeks.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Males and females aged 20 to 59 years old
2.Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
1.Subjects who are under treatment or have a history of disease such as serious cardiovascular disease and digestive system disease
2.Subjects who take antibiotics
3.Subjects who continuously use intestinal regulators
4.Subjects who continuously use functional foods affecting the intestinal environment (taking lactic acid bacteria, bifidobacteria and other bacteria, or foods such as yoghurt and natto, are not exclusionary conditions)
5.Subjects who are judged as unsuitable for the study by the test administrator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Teruki |
| Middle name | |
| Last name | Aizawa |
Organization
Yaizu Suisankagaku Industry Co., Ltd.
Division name
Research & Development Dept.
Zip code
425-8570
Address
5-8-13 Kogawashinmachi, Yaizu-City, Shizuoka Pref.
TEL
054-621-0112
t-aizawa@yskf.co.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Yamamoto |
Organization
Yaizu Suisankagaku Industry Co., Ltd.
Division name
Research & Development Dept.
Zip code
425-8570
Address
5-8-13 Kogawashinmachi, Yaizu-City, Shizuoka Pref.
TEL
054-621-0112
Homepage URL
a-yamamoto@yskf.co.jp
Sponsor or person
Institute
Yaizu Suisankagaku Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yaizu Suisankagaku Industry 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
Research Ethics Committee of Yaizu Suisankagaku Industry Co., Ltd.
Address
11-1 Minamicho, Suruga-ku, Shizuoka-City, Shizuoka Pref.
Tel
054-202-6030
head-office@yskf.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
| 2024 | Year | 06 | Month | 13 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062383
