UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044571 |
|---|---|
| Receipt number | R000050505 |
| Scientific Title | Acquisition of basic information on the profile of intestinal microbiota and metabolites in the human caused by changes in environmental factors |
| Date of disclosure of the study information | 2021/06/17 |
| Last modified on | 2021/06/17 09:55:48 |
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Basic information
Public title
Acquisition of basic information on the profile of intestinal microbiota and metabolites in the human caused by changes in environmental factors
Acronym
Acquisition of basic information on the profile of intestinal microbiota and metabolites in the human caused by changes in environmental factors
Scientific Title
Acquisition of basic information on the profile of intestinal microbiota and metabolites in the human caused by changes in environmental factors
Scientific Title:Acronym
Acquisition of basic information on the profile of intestinal microbiota and metabolites in the human caused by changes in environmental factors
Region
| Japan |
Condition
Condition
Healthy male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of daily dietary changes on the intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal environment evaluation based on microbiota analysis and metabolomic analysis
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
(1) no restriction on diet: 7 days
(2) subjects ate provided meals: 7 days
(3) subjects continuously ate an identical meal 15 times: 5 days
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy individuals
(2) Subjects who have been fully informed of the purpose and content of the research in writing and orally, and have given their consent.
Key exclusion criteria
Subjects with intestinal diseases, skin diseases, or allergies to specified diets.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Tomita |
Organization
Keio University
Division name
Faculty of environment and information studies
Zip code
9970052
Address
246-2, Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
0235-29-0800
mt@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Keio University
Division name
Graduate school of media and governance
Zip code
9970052
Address
246-2, Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
0235-29-0800
Homepage URL
sfukuda@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
The Japan Science Society
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SFC Research Ethics Committee
Address
5322 Endo, Fujisawa, Kanagawa, Japan
Tel
0466-49-3404
rinri@sfc.keio.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
32
Results
Preparing to submit paper
Results date posted
| 2021 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
23-55 years old
Participant flow
Inclusion: 32 subjects
Dropout: 2 subjects
Missing necessary background information: 5 subjects
Subjects for analysis: 25 subjects (male: 9, female: 16)
Adverse events
None
Outcome measures
Preparing to submit paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 17 | Day |
Last modified on
| 2021 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050505
| 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 |
