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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022663
Receipt No. R000026120
Scientific Title Effect on the intestinal flora of food
Date of disclosure of the study information 2016/06/08
Last modified on 2019/03/25

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Basic information
Public title Effect on the intestinal flora of food
Acronym Effect on the intestinal flora of food
Scientific Title Effect on the intestinal flora of food
Scientific Title:Acronym Effect on the intestinal flora of food
Region
Japan

Condition
Condition bowel movement
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By ingesting the food, we reveal the dynamics of intestinal flora.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Using a bacteriological examination, we analyzes the variation of the intestinal flora.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Consume a specific food.
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
25 years-old >=
Gender Male and Female
Key inclusion criteria Third grader and forth grader of Tokyo University of Agriculture Nutrition Science
Key exclusion criteria A person who has not obtained the consent in this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name kazuhiro
Middle name
Last name homma
Organization Tokyo University of Agriculture Faculty of Applied Bio-Science, Nutrition Science
Division name Clinical nutrition laboratory
Zip code 156-8502
Address Setagaya-ku, Tokyo Sakuragaoka- 1-1-1
TEL 03-5477-2449
Email hommma-tua@umin.ac.jp

Public contact
Name of contact person
1st name kazuhiro
Middle name
Last name homma
Organization Tokyo University of Agriculture Faculty of Applied Bio-Science, Nutrition Science
Division name Clinical nutrition laboratory
Zip code 156-8502
Address Setagaya-ku, Tokyo Sakuragaoka- 1-1-1
TEL 03-5477-2449
Homepage URL
Email hommma-tua@umin.ac.jp

Sponsor
Institute Tokyo University of Agriculture Faculty of Applied Bio-Science, Nutrition Science
Institute
Department

Funding Source
Organization Tokyo University of Agriculture Faculty of Applied Bio-Science, Nutrition Science
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 Tokyo University of Agriculture
Address Setagaya-ku, Tokyo Sakuragaoka- 1-1-1
Tel 03-5477-2449
Email homma-tua@umin.ac.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 東京農業大学(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 08 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 15
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
2016 Year 06 Month 08 Day
Date of IRB
2016 Year 08 Month 02 Day
Anticipated trial start date
2016 Year 08 Month 08 Day
Last follow-up date
2021 Year 03 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
2016 Year 06 Month 08 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026120

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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