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NCT05560087 Clinical Trial

Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)

Periodontitis Clinical Trial

Official title:
Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05560087
Other study ID # 4-2022-0533
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2022
Est. completion date December 2024

Study information
Verified date February 2023
Source Yonsei University
Contact Jong-Won Ha
Phone 82-2-2228-8460
Email jwha@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to explore the relationship between periodontal disease and coronary artery disease through changes in the gut microbiome. In addition, the investigators aim to find possible periodontal pathogens that have association with cardiovascular disease.

Description:

The previous studies have reported the associations among cardiovascular disease, periodontitis, and gut microbiome dysbiosis. However, there is a lack of evidences about the axis of association from oral-gut-cardiovascular disease. The investigators hypothesized that periodontal disease might induce dysbiosis of gut microbiome and dysbiosis might have a role in cardiovascular disease (as called "oro-gut-vascular axis"). The investigators aim to prove this hypothesis through this case-control, cross-sectional study.

Recruitment information / eligibility
Status Recruiting
Enrollment 580
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: -Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent Exclusion Criteria: - Patients with prosthetic valve - pregnancy - active malignancy - active autoimmune disease - active inflammatory bowel disease - chronic kidney disease (eGFR<30, or on dialysis) - Active liver disease or liver cirrhosis - consistent use of probiotics - prior gastrointestinal surgery within 1 year

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The association between periodontal disease and cardiovascular disease The association between periodontal disease and cardiovascular disease by chi-square test The difference of relative abundance in gut microbiome by PERMANOVA test Safety Issue: No within 3 years after enrollment (until the completion of dataset)
Secondary The associations among periodontitis, gut microbiome and biomarkers The association between periodontal disease and biomarkers by independent t-test within 3 years after enrollment (until the completion of dataset)
Secondary The associations between periodontitis and cognitive function The associtation between periodontal disease and cognitive function by chi-square test within 3 years after enrollment (until the completion of dataset)
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