UMIN-CTR Clinical Trial
| Recruitment status | Enrolling by invitation |
| Unique ID issued by UMIN | UMIN000015703 |
| Receipt No. | 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 (Ver. 5) |
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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 |
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| Condition | ||
| Condition | coronary artery disease | |
| Classification by specialty |
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| 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
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| 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 |
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| Age-upper limit |
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| 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. |
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| 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 |
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| 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 | ||||||
| hiratak@med.kobe-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| 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 | |||||||
| tomoya@med.kobe-u.ac.jp | |||||||
| Sponsor | |
| Institute | Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine |
| Institute | |
| Department | |
| 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 |
| 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 |
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| 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 |
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| Date of IRB | |||||||
| Anticipated trial start date |
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| 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 |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018051 |
