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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dysbiosis
• Heart Diseases
• Human Microbiome
• Myocardial Ischemia
• Periodontal Diseases
• Periodontitis

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)