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Clinical Trials in Italy / NCT07429227
Recruiting Not applicable

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.

NCT07429227 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-03
Last updated
2026-02-24

Condition(s) studied

Acute Coronary Syndromes (ACS)

Investigational drug(s) / intervention(s)

Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant

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

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ospedale P. Pederzoli Casa di Cura Privata S.p.A. Peschiera del Garda Verona Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07429227 on ClinicalTrials.gov ↗ ← All trials in Italy