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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034099
Receipt No. R000038865
Scientific Title Safty comfirmation examination of the plant fermentation extract IL
Date of disclosure of the study information 2018/09/11
Last modified on 2018/09/11

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Basic information
Public title Safty comfirmation examination of the plant fermentation extract IL
Acronym Safty comfirmation examination of the plant fermentation extract IL
Scientific Title Safty comfirmation examination of the plant fermentation extract IL
Scientific Title:Acronym Safty comfirmation examination of the plant fermentation extract IL
Region
Japan

Condition
Condition healthy people and mild constipation
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We confirm safety about intakes for 25ml per day in "the plant fermentation extract IL" about 4 weeks
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We perform the blood test before and after "plant fermentation extract IL" intake and confirm safety.
Key secondary outcomes

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 Treatment
Type of intervention
Food
Interventions/Control_1 The subjects eat the test meal each day per 25ml for 4 weeks. Then we carry out the blood tests at baseline and after 4weeks.
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
75 years-old >
Gender Female
Key inclusion criteria 1)The person who does not take medicine for treatment
2) The tendency to slight constipation (in a week 2-4 times)
3) The person who does not take bowel movement improvement medicine for examination one month.
4) The person who, during the test, can do it constantly in life.
5) The one that was admitted by the judgment of the examination responsibility doctor
Key exclusion criteria 1) The one with a serious disease.
2) A disease anamnesis and the alimentary system with the operation calendar of the digestive organs.
3) The person who, during the test, cannot do it constantly in life.
4) Is the person with allergy for test food.
5) The person who is pregnant, and hopes for the pregnancy during an examination.
6) The doctor examination responsibility who was ineligible by a judgment.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tanaka
Organization Kagawa Nutrition University
Division name Nutrition Clnic
Zip code
Address 3-34-3,Komagome,Tosima-ku,Tokyo
TEL 03-3918-6181
Email clinic@eiyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Kamachi
Organization Kagawa Nutrition University
Division name Nutrition Clinic
Zip code
Address 3-24-3,Komagome,Tosima-ku,Tokyo
TEL 03-3918-6181
Homepage URL
Email clinic@eiyo.ac.jp

Sponsor
Institute kagawa nutrition university
Institute
Department

Funding Source
Organization International food Co.Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 11 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
2018 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038865

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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