UMIN-CTR Clinical Trial

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
Institute	Kobe University Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040058