UMIN-CTR Clinical Trial

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

Adult female in good health

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Microflora, by 16S metagenome analysis.

Key secondary outcomes

Metabolite in intestine, by metabolome analysis.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Katsuhisa
Middle name
Last name	Sakano

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Suguru
Middle name
Last name	Fujiwara

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

MetaGen, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

CPCC Company Limited

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2016

Year

10

Month

13

Day

Last modified on

2020

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028075