Restoring gut balance with natural and probiotic extracts for people with acute coronary syndromes
Metabolomic and Cellular Inflammaging Investigation Study of Patients With Acute Coronary Syndrome (ACS)
This test checks whether high-bioavailability essential oil formulations and probiotic approaches can restore healthy gut bacteria in adults aged 30–70 hospitalized with acute coronary syndromes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Casa di Cura Dott. Pederzoli Academic / other |
| Drugs / interventions | Evolocumab, Alirocumab |
| Locations | 1 site (Peschiera del Garda, Verona) |
| Trial ID | NCT07429227 on ClinicalTrials.gov |
What this trial studies
Patients admitted with unstable angina or acute myocardial infarction provide baseline urine and blood samples at admission and additional timed urine samples over the first 24 hours to capture intestinal permeability and dysbiosis markers. Participants then receive a two-month course of specified essential oil formulations and non-pharmacological therapy and return for a first-morning urine collection for metabolomics and dysbiosis testing. The study compares the initial 'snapshot' of gut-related biomarkers to the results after two months and records any adverse events or treatment discontinuations. Individuals using certain lipid-lowering drugs or with major comorbidities are excluded to reduce confounding.
Who should consider this trial
Good fit: Adults aged 30–70 with a confirmed diagnosis of acute coronary syndrome (unstable angina or AMI) who can give informed consent and are not taking excluded lipid-lowering medications are eligible.
Not a fit: People with HIV, cancer, type 1 or type 2 diabetes, those taking excluded lipid-lowering drugs or nutraceuticals, and pregnant women are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer a non-drug approach to help restore gut balance after an acute coronary event, potentially lowering inflammation-related complications.
How similar studies have performed: Some prior small studies have linked microbiome changes to cardiovascular risk, but using targeted high-bioavailability essential oil formulations in ACS patients is largely novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Signing of informed consent * 2\. Diagnosis of Acute Coronary Syndrome (ACS) * 3\. Age 30-70 Exclusion Criteria: 1. Use in the three months preceding the signing of the informed consent of: i) Lipid-lowering drugs containing statins, ezetimibe, fibrates ii) Lipid-lowering nutraceuticals containing monacolin K iii) Monoclonal antibodies that inhibit PCSK9 (proprotein convertase subtilisin/kexin type 9) such as Evolocumab and Alirocumab 2. Diagnosis of conditions such as HIV, cancer and diabetes I and II Furthermore, if a female patient becomes pregnant during the trial, this will be one of the reasons for early exit from the study.
Where this trial is running
Peschiera del Garda, Verona
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda, Verona, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.