NCT07429227

Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

Metabolomic and Cellular Inflammaging Investigation Study of Patients With Acute Coronary Syndrome (ACS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Casa di Cura Dott. Pederzoli · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The prospective experimental study aims to take an instantaneous photograph of the subject at time T0 and after 24 hours of intestinal permeability and dysbiosis indices in patients with acute coronary syndromes (ACS) which include unstable coronary artery disease (unstable angina) and acute myocardial infarction (AMI). The aim is to verify whether essential oils in particular formulations with high bioavailability are able to re-establish intestinal eubiosis after 2 months, confirmed by tests laboratory specifics such as metabolomics.

Detailed description

The subject arrives at the experimental center at time T0 to proceed with the hospital admission as scheduled. At time T0, during the visit, information regarding demographics, BMI, height, weight, etc... is collected. The subject will be subjected to a screening questionnaire, useful for collecting general information. After the visit with the medical examiner, three first-micturition urine samples, a serum sample, and a complete blood count test tube will be collected and blood tests will be performed, as per clinical practice. The subject will then be admitted to the experimental center. After 6 hours from the T0 visit, a second urine collection will be performed as per clinical practice (two samples per subject). After 12 hours from the T0 visit, a third urine collection will be performed as per clinical practice (two samples per subject) After 24 hours from the T0 visit, a fourth urine collection will be collected as per clinical practice (two samples per subject). At the end of the two months of drug and non-pharmacology therapy, patients will have to return to the experimental center for the second phase of the study. In this second phase, only first-micturition urine will be collected, which will serve to complete the metabolomics and intestinal dysbiosis data. Finally, all objective adverse events reported or reported by patients during pharmacological and non-pharmacological treatment will be recorded, particularly those that led to treatment discontinuation.

Conditions

• Acute Coronary Syndromes (ACS)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant	Patients will take 2 capsules/day of the product

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Italy