UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022663 |
|---|---|
| Receipt number | 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 15:48:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hommma-tua@umin.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture Faculty of Applied Bio-Science, Nutrition Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026120
