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
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
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
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
