UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027857 |
|---|---|
| Receipt number | R000031918 |
| Scientific Title | Assessment of safety and effective dose of a food thought to improve the intestinal environment. |
| Date of disclosure of the study information | 2017/06/21 |
| Last modified on | 2018/01/02 13:24:39 |
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Basic information
Public title
Assessment of safety and effective dose of a food thought to improve the intestinal environment.
Acronym
Safety of a food thought to improve the intestinal environment.
Scientific Title
Assessment of safety and effective dose of a food thought to improve the intestinal environment.
Scientific Title:Acronym
Safety of a food thought to improve the intestinal environment.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety of daily intake of a food thought to improve the intestinal environment and determine the effective dose.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Interview with a doctor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Male subjects, who take 1 stick of a food thought to improve the intestinal environment daily for 3 months.
Interventions/Control_2
Female subjects, who take 1 stick of a food thought to improve the intestinal environment daily for 3 months.
Interventions/Control_3
Male subjects, who take 2 sticks of a food thought to improve the intestinal environment daily for 3 months.
Interventions/Control_4
Female subjects, who take 2 sticks of a food thought to improve the intestinal environment daily for 3 months.
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. Those who can understand the purpose and contents of this study and agree by letter to participate.
2. Those who have been diagnosed with a tendency to constipation after responding to a questionnaire.
Key exclusion criteria
1. Pregnant women, breast feeding mothers
2. Those who are taking medication for a disease of the digestive organs (including constipation symptoms), that affects gastrointestinal function.
3. Those who have a disease.
4. Those who have an allergy to fruit.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Shunji Mizobuchi |
Organization
Kochi Medical School, Kochi University
Division name
Clinical nursing
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
088-866-5811
mizoshun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Mizobuchi |
Organization
Kochi Medical School, Kochi University
Division name
Clinical nursing
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
088-880-2564
Homepage URL
mizoshun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation
KOCHI INDUSTRIAL PROMOTION CENTER
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Umajimura agricultural cooperative
MUSE Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
高知大学医学部（高知県）、高知大学医学部附属病院（高知県）、医療法人 仁泉会 朝倉病院（高知県）、馬路村立馬路診療所（高知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 21 | 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
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 17 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 21 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031918
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
