UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024389
Receipt No. R000028075
Scientific Title Construction of intestinal environment database of the Japanese
Date of disclosure of the study information 2016/10/13
Last modified on 2017/08/10

* 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 Construction of intestinal environment database of the Japanese
Acronym Construction of intestinal environment database of the Japanese
Scientific Title Construction of intestinal environment database of the Japanese
Scientific Title:Acronym Construction of intestinal environment database of the Japanese
Region
Japan

Condition
Condition Adult female in good health
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Monitoring of the intestinal environmental change in healthy females who live an ordinary life for 24-weeks.
Basic objectives2 Others
Basic objectives -Others Construction of intestinal environment database of the Japanese
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Microflora, by 16S metagenome analysis.
Key secondary outcomes Metabolite in intestine, by metabolome analysis.

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
30 years-old <=
Age-upper limit
59 years-old >
Gender Female
Key inclusion criteria (1)Subjects who can visit to a designated clinic on scheduled inspection date.
(2) Subjects who understand the explanation about this study given beforehand and submit written informed consent to participate in the study.
Key exclusion criteria (1) Subjects who are under continuous treatment of medical supplies.
(2) Females who are pregnant (including the possibility of pregnancy) or are lactating.
(3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study.
(4) Females whose blood was collected more than 400 mL within the last 16-weeks.
(5) Females whose blood was collected more than 800 mL within the last 12-months when the amount of blood sampling in the current study is added.
(6) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within 4-weeks.
(7)Subjects who are heavy drinkers of alcohol and/or are excessive smokers (smoking 21 and more per day).
(8) Subjects who have an excessive irregular meal cycle, a work shift or a work on midnight shift.
(9)Subject who are true to one of the below.
a) Subject who are suffering from heart, liver or kidney disease, including the case of complications of other disease.
b) Subjects who are suffering from diabetes.
(10) Subjects who have long trip planning during test period.
(11) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Fujiwara
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization MetaGen, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 13 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
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 08 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Cross sectional study
Subject recruitment method: Sixty females among the subjects who voluntary participate in the pre-inspection which carried out in our institution between from October 13 and October 17, and meet the selection criteria.

Management information
Registered date
2016 Year 10 Month 13 Day
Last modified on
2017 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.