UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study for intestinal environment markers.
Title of the study (Brief title)	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	Norihito Murayama
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
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	Kenichi Wakabayashi
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
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
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033658