PeriodontitisNCT05560087
Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)
An observational study of Periodontitis and Coronary Heart Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Periodontitis, Coronary Heart Disease, Human Microbiome
- How many people
- 450 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 5 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity in single tertiary hospital
Who may be able to join
- -Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent
Who cannot join
- Patients with prosthetic valve
- pregnancy
- active malignancy
- active autoimmune disease
- active inflammatory bowel disease
- chronic kidney disease (eGFR<30, or on dialysis)
Show all 9Show fewer
- Active liver disease or liver cirrhosis
- consistent use of probiotics
- prior gastrointestinal surgery within 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
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.
Read the 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.
- Conditions
- Periodontitis, Coronary Heart Disease, Human Microbiome, Dysbiosis
- Medical subject headings
- Periodontitis, Coronary Disease, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery disease | Not described | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 3 years after enrollment (until the completion of dataset)
Secondary outcomes (2)
The associations among periodontitis, gut microbiome and biomarkers
The association between periodontal disease and biomarkers by independent t-test
Measured: within 3 years after enrollment (until the completion of dataset)
The associations between periodontitis and cognitive function
The associtation between periodontal disease and cognitive function by chi-square test
Measured: within 3 years after enrollment (until the completion of dataset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jul 2022
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Won Ha, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560087
- Sponsor's protocol ID
- 4-2022-0533
- Status last verified
- Dec 2024
- First submitted
- 19 Sep 2022
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)
- ClinicalTrials.gov ID
- NCT05560087
- Acronym / sponsor ID
- 4-2022-0533
- Conditions
- Periodontitis, Coronary Heart Disease, Human Microbiome, Dysbiosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary artery disease | – | – |
| control | – | – |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity in single tertiary hospital
Key inclusion criteria (1 listed)
- -Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent
Key exclusion criteria (9 listed)
- Patients with prosthetic valve
- pregnancy
- active malignancy
- active autoimmune disease
- active inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The association between periodontal disease and cardiovascular disease
Time frame: 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
2 secondary outcomes
The associations among periodontitis, gut microbiome and biomarkers
Time frame: within 3 years after enrollment (until the completion of dataset)
The associations between periodontitis and cognitive function
Time frame: within 3 years after enrollment (until the completion of dataset)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Won Ha principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Coronary Heart Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between periodontal disease and cardiovascular disease (time frame: within 3 years after enrollment (until the completion of dataset)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.