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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027857
Receipt No. 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

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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
Email 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
Email mizoshun@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031918

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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