UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029687
Receipt number R000033658
Scientific Title Exploratory study for intestinal environment markers.
Date of disclosure of the study information 2017/10/24
Last modified on 2017/11/16 10:47:19

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Basic information

Public title

Exploratory study for intestinal environment markers.

Acronym

Exploratory study for intestinal environment markers.

Scientific Title

Exploratory study for intestinal environment markers.

Scientific Title:Acronym

Exploratory study for intestinal environment markers.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To search blood markers reflecting intestinal environment

Basic objectives2

Others

Basic objectives -Others

To search blood markers

Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between results of existing test and blood protein A levels

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Subjects aged 20 or more years-old
2) Subjects whose blood protein A is above the lower limit of quantification
3) Subjects who can visit hospital on designated day
4) Subjects giving written informed consent

Key exclusion criteria

1) Subjects whose systolic blood pressure is less than 90mmHg
2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study
4) Males whose blood was collected more than 400 mL within the last three months
5) Females whose blood was collected more than 400 mL within the last four months
6) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added
7) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added
8) Diabetic patients
9) Subjects who have allergic reactions to sugar alcohols
10) Subjects who are on lactose-restricted diet
11) Subjects who have any one of diseases in heart, liver, kidney or gastrointestinal tract
12) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks
13) Subjects with a previous history of cardiovascular disease and digestive tract disease
14) Subjects who have allergic reaction to drug medicine
15) Subjects who drink alcohol a lot and smoke a lot
16) Subjects who have an irregular sleep cycle, work shift or work on midnight shift
17) Subjects who constantly use drug medicine affecting the test results
18) 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 Norihito Murayama

Organization

Suntory Global Innovation Center Ltd.

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0588

Email

Norihito_Murayama@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Wakabayashi

Organization

Suntory Global Innovation Center Ltd.

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0599

Homepage URL


Email

Kenichi_Wakabayashi@suntory.co.jp


Sponsor or person

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name



Funding Source

Organization

Suntory Global Innovation Center Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



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

福原医院 (北海道)


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 24 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

No longer recruiting

Date of protocol fixation

2017 Year 10 Month 06 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Correlation between results of existing test and blood protein A levels


Management information

Registered date

2017 Year 10 Month 24 Day

Last modified on

2017 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name