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 | Recruiting DMC

• 1 other identifier: 748CET
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndromes (ACS)

Keywords

intestinal permeability; unstable coronary artery disease; acute myocardial infarction; metabolomic; essential oils; dietary supplement; dysbiosis

Outcome Measures

Primary Outcomes (1)

• characterization of urinary metabolites

  to assess the presence of dysmetabolisms

  through study completion, an average of 1 year

Secondary Outcomes (2)

• state of metabolic cardio risk

  through study completion, an average of 1 year

• urinary dysmetabolism

  through study completion, an average of 1 year

Study Arms (1)

non-pharmacological therapy arm

OTHER

after discharge from the experimental center the subject will be prescribed drug therapy, as directed by the medical experimenter, and non-drug therapy. For the next 2 months, in addition to conventional therapy, each individual will be combined with non-pharmacological therapy consisting of essential oils and a post- and prebiotic component.

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

Interventions

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

Patients will take 2 capsules/day of the product

non-pharmacological therapy arm

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Signing of informed consent
• \. Diagnosis of Acute Coronary Syndrome (ACS)
• \. Age 30-70

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead
• Herboplanet Srl: collaborator

Study Sites (1)

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Dysbiosis

Interventions

G-Protein-Coupled Receptor Kinase 2

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta-Adrenergic Receptor Kinases; G-Protein-Coupled Receptor Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: to each individual subject will be associated, in addition to conventional therapy, a non-pharmacological therapy consisting of essential oils and post and prebiotic component

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)