UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015703
Receipt number R000018051
Scientific Title The interaction between gut microbiota and atherosclerosis
Date of disclosure of the study information 2014/11/20
Last modified on 2020/11/20 13:40:46

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Basic information

Public title

The interaction between gut microbiota and atherosclerosis

Acronym

Gut microbiota and atherosclerosis

Scientific Title

The interaction between gut microbiota and atherosclerosis

Scientific Title:Acronym

Gut microbiota and atherosclerosis

Region

Japan


Condition

Condition

coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To clarify the composition of gut microbiota in patients with coronary artery disease, compared with controls without coronary artery disease.

Basic objectives2

Others

Basic objectives -Others

Observation of the change of gut microbiota in coronary artery disease

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

gut microbiota

Key secondary outcomes

the metabolites of gut microbiota


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Coronary artery disease patients who were diagnosed by coronary angiography

Controls without coronary artery disease who have diabetes, dyslipidemia, or hypertension.

Key exclusion criteria

Patients with collagen disease, malignancy, kidney disease, or liver disease

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Ken-ichi
Middle name
Last name Hirata

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code

650-0017

Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-5846

Email

hiratak@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Tomoya
Middle name
Last name Yamashita

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code

650-0017

Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan.

TEL

078-382-5846

Homepage URL


Email

tomoya@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

a Translational Research Grant from Japan Circulation Society

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Tokyo Institute of Technology

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe University

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan

Tel

078-382-5846

Email

tomoya@med.kobe-u.ac.jp


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

2014 Year 11 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

A characteristic change of gut microbiota was observed in CAD patients, where the order Lactobacillales was increased and the phylum Bacteroidetes was decreased.

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

Enrolling by invitation

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

case control study


Management information

Registered date

2014 Year 11 Month 16 Day

Last modified on

2020 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018051


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name