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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019720
Receipt No. R000022776
Scientific Title Change of intestinal flora pattern with food intake
Date of disclosure of the study information 2015/11/10
Last modified on 2020/05/14

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Basic information
Public title Change of intestinal flora pattern with food intake
Acronym Verification of intestinal flora pattern
Scientific Title Change of intestinal flora pattern with food intake
Scientific Title:Acronym Verification of intestinal flora pattern
Region
Japan

Condition
Condition Patients and healthy control
Classification by specialty
Medicine in general Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the changes of intestinal flora by food intake
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes of intestinal flora
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those obtained written informed consent
Key exclusion criteria Those have allergy
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Tetsuro
Middle name
Last name Takayama
Organization Wata clinic
Division name Internal medicine
Zip code 1250052
Address ARB 1F, 1-2-1 Shibamata, Katsushika-ku, Tokyo
TEL 03-5648-7025
Email t2takayama@msn.com

Public contact
Name of contact person
1st name Tetsuro
Middle name
Last name Takayama
Organization Wata clinic
Division name Internal medicine
Zip code 1250052
Address ARB 1F, 1-2-1 Shibamata, Katsushika-ku, Tokyo
TEL 03-5648-7025
Homepage URL
Email t2takayama@msn.com

Sponsor
Institute Wata clinic
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Wata clinic
Address ARB 1F, 1-2-1 Shibamata, Katsushika-ku, Tokyo
Tel 03-5648-7025
Email wata-cl@gf7.so-net.ne.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
2015 Year 11 Month 10 Day

Related information
URL releasing protocol terminated
Publication of results Unpublished

Result
URL related to results and publications terminated
Number of participants that the trial has enrolled 0
Results
terminated
Results date posted
2020 Year 05 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
terminated
Participant flow
terminated
Adverse events
terminated
Outcome measures
terminated
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 10 Month 27 Day
Date of IRB
2015 Year 08 Month 02 Day
Anticipated trial start date
2015 Year 11 Month 10 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Verification of intestinal flora pattern.

Management information
Registered date
2015 Year 11 Month 09 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022776

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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