UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035210
Receipt number R000040058
Scientific Title The association between the gut microbiome and venous thromboembolism
Date of disclosure of the study information 2019/02/01
Last modified on 2020/07/28 11:33:34

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Basic information

Public title

The association between the gut microbiome and venous thromboembolism

Acronym

The association between the gut microbiome and venous thromboembolism

Scientific Title

The association between the gut microbiome and venous thromboembolism

Scientific Title:Acronym

The association between the gut microbiome and venous thromboembolism

Region

Japan


Condition

Condition

venous thromboembolism

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify intestinal bacterial flora and fecal metabolite specific to patients with venous thrombosis

Basic objectives2

Others

Basic objectives -Others

To examine the relationship between intestinal bacteria and venous thrombosis by measuring blood metabolites

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composition of intestinal bacterial flora and LPS production

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.Patients diagnosed with venous thrombotic diseases (including deep vein thrombosis, pulmonary embolism, chronic thromboembolic pulmonary hypertension) with contrast CT, angiography examination, limb vein echo
2.There is consent to written participation in this clinical study
3.The age at consent acquisition is over 20 years old

Key exclusion criteria

1.Patients who can not obtain consent from this clinical study
2.Patient with past history of autoimmune disease, patient taking steroid
3.atients with a history of bowel disease and patients after intestinal surgery (excluding appendicitis resection)
4.Patients with active infections, patients receiving antibiotics
5.Patient with cancer or within 5 years after cancer treatment
6.Patients with high frailty
7.Pregnant
8.Other patients who are judged inappropriate by researchers

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoya Yamashita

Organization

Kobe University Hospital

Division name

Cardiology

Zip code


Address

7-5-2 Kusunoki-cho Chuou-ku Kobe-shi Hyogo

TEL

078-382-5846

Email

tomoya@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoya Yamashita

Organization

Kobe University Hospital

Division name

Cardiology

Zip code


Address

7-5-2 Kusunoki-cho Chuou-ku Kobe-shi Hyogo

TEL

078-382-5846

Homepage URL


Email

tomoya@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kobe University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 01 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

0

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

Terminated

Date of protocol fixation

2019 Year 01 Month 01 Day

Date of IRB

2019 Year 03 Month 07 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2020 Year 02 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Composition of intestinal bacterial flora and LPS production


Management information

Registered date

2018 Year 12 Month 10 Day

Last modified on

2020 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name