UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047969 |
|---|---|
| Receipt number | R000054683 |
| Scientific Title | confirmation test about improvements of intestinal environment by test-food intake |
| Date of disclosure of the study information | 2022/06/06 |
| Last modified on | 2024/06/18 17:58:29 |
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Basic information
Public title
confirmation test about improvements of intestinal environment by test-food intake
Acronym
confirmation test about improvements of intestinal environment by test-food intake
Scientific Title
confirmation test about improvements of intestinal environment by test-food intake
Scientific Title:Acronym
confirmation test about improvements of intestinal environment by test-food intake
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate whether test-food intake can improve intestinal microflora
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amplicon sequence analysis of changes in the behavior of intestinal microflora and bowel movement situation(frequency, number of days, amount, nature)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
consumption of the test food(1capsule/ once a day) to the subjects after supper
Interventions/Control_2
consumption of the placebo food(1capsule/once a day) to the subjects after supper
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) healthy male/female subjects ranging in age from 18 to 60
(2)subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.
(3) subjects who do not regularly intake laxatives
Key exclusion criteria
(1)subjects with previous medical history of drug and /or food allergy (especially in a soybean)
(2)subjects some kind of medical treatment continuously
(3)subjects who took probiotics, prebiotics, antacids, or non-steroidal anti-inflammatory drugs, excluding the research product, within the last 3 weeks of taking the test food
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Onodera |
Organization
KOEI SCIENCE LABORATORY Co., Ltd.
Division name
President and Representative Director
Zip code
351-0115
Address
5-1-25, niikura, wako-shi, saitama, 351-0115, japan
TEL
0484673345
onodera@koei-science.com
Public contact
Name of contact person
| 1st name | Sumie |
| Middle name | |
| Last name | Sugawara |
Organization
KOEI SCIENCE LABORATORY Co., Ltd.
Division name
planning room
Zip code
3510115
Address
5-1-25, niikura, wako-shi, saitama, 351-0115, japan
TEL
0484673345
Homepage URL
sugawara@koei-science.com
Sponsor or person
Institute
KOEI SCIENCE LABORATORY Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOEI SCIENCE LABORATORY 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
KOEI SCIENCE LABORATORY Research Ethics Committee
Address
5-1-25, niikura, wako-shi, saitama, 351-0115, japan
Tel
0484673345
ooya@koei-science.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
| 2022 | Year | 06 | Month | 06 | 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
18
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 | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054683
