UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018128 |
|---|---|
| Receipt number | R000020997 |
| Scientific Title | Analysis of intestinal metabolite and microbiota by endoscopic retrograde bowel insertion method |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2017/12/26 11:13:27 |
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Basic information
Public title
Analysis of intestinal metabolite and microbiota by endoscopic retrograde bowel insertion method
Acronym
Microbiota analysis by ERBI
Scientific Title
Analysis of intestinal metabolite and microbiota by endoscopic retrograde bowel insertion method
Scientific Title:Acronym
Microbiota analysis by ERBI
Region
| Japan |
Condition
Condition
Healty adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of intestinal metabolite and microbiota by endoscopic retrograde bowel insertion method
Basic objectives2
Others
Basic objectives -Others
Sequencial measurement of colony forming units and metabolite of lactic acid bacteria at terminal ileum after ingestion of a fermented milk drink
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Colony forming units by culture method
Key secondary outcomes
FISH analysis, organic acid concentration, DNA microarray
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A subject takes one bottle of fermented milk drink. It takes less than 9 hours.
Interventions/Control_2
A subject takes one bottle of placebo drink. It takes less than 9 hours.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Subject with gastrointestinal disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsaku Fukuda |
Organization
Hirosaki University Graduate School of Medicine
Division name
Gastroenterologyand Hematology
Zip code
Address
5 Zaifu-cho, Hirosaki
TEL
0172-39-5053
sfukuda@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsaku Fukuda |
Organization
Hirosaki University Graduate School of Medicine
Division name
Gastroenterologyand Hematology
Zip code
Address
5 Zaifu-cho, Hirosaki
TEL
0172-39-5053
Homepage URL
sfukuda@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
弘前大学大学院医学研究科/ Hirosaki University Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2017 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020997
| 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 |
