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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05560087

Enrollment

450

Registered

2022-09-29

Start date

2022-07-01

Completion date

2024-12-05

Last updated

2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Dysbiosis, Human Microbiome, Periodontitis

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The association between periodontal disease and cardiovascular disease	within 3 years after enrollment (until the completion of dataset)	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

Secondary

Measure	Time frame	Description
The associations among periodontitis, gut microbiome and biomarkers	within 3 years after enrollment (until the completion of dataset)	The association between periodontal disease and biomarkers by independent t-test
The associations between periodontitis and cognitive function	within 3 years after enrollment (until the completion of dataset)	The associtation between periodontal disease and cognitive function by chi-square test

Countries

South Korea

Outcome results