UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Isolation of bacterial strains from human feces and its therapeutic applications
Title of the study (Brief title)	Isolation of bacterial strains from human feces
Region	Japan

Condition
Condition	cardiovascular disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Isolation of bacterial strains from feces of human with or without cardiovascular disease.
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Confirm whether we successfully isolate the bacterial strains using polymerase chain reaction.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. healthy volunteers 2. patients with risk factor of cardiovascular disease 3. patients with cardiovascular disease
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	Tomoya Yamashita
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5846
Email	tomoya@med.kobe-u.ac.jp

Public contact
Name of contact person	Tomoya Yamashita
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5846
Homepage URL
Email	tomoya@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

Funding Source
Organization	Kobe university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	NITTO PHARMACEUTICAL INDUSTRIES
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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 01 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	In the future, we use the isolated bacterial strains for reserch.

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2017 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032287