Acute Coronary Syndromes (ACS)DISBIONCT07429227
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.
A study testing Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant in people with Acute Coronary Syndromes (ACS), run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Acute Coronary Syndromes (ACS)
- What is being tested?
- Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Signing of informed consent
- 2. Diagnosis of Acute Coronary Syndrome (ACS)
- 3. Age 30-70
Who cannot join
- Use in the three months preceding the signing of the informed consent of:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Antonio Fusco, MD, +39 0456444193, urc@ospedalepederzoli.it
About this study
Official title: Metabolomic and Cellular Inflammaging Investigation Study of Patients With Acute Coronary Syndrome (ACS)
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.
Read the 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)
- Being tested
- Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant
- Keywords
- intestinal permeability, unstable coronary artery disease, acute myocardial infarction, metabolomic, essential oils, dietary supplement, dysbiosis
- Medical subject headings
- Acute Coronary Syndrome, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plantDietary supplement
Patients will take 2 capsules/day of the product
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterization of urinary metabolites
to assess the presence of dysmetabolisms
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
state of metabolic cardio risk
picture of all the pro-atherogenic factors
Measured: through study completion, an average of 1 year
urinary dysmetabolism
interaction of non-pharmacological therapy and urinary dysmetabolisms
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Herboplanet Srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429227
- Sponsor's protocol ID
- 748CET
- Acronym
- DISBIO
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic and Cellular Inflammaging Investigation Study of Patients With Acute Coronary Syndrome (ACS)
- ClinicalTrials.gov ID
- NCT07429227
- Acronym / sponsor ID
- DISBIO / 748CET
- Conditions
- Acute Coronary Syndromes (ACS)
- Keywords
- intestinal permeability, unstable coronary artery disease, acute myocardial infarction, metabolomic, essential oils, dietary supplement, dysbiosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Collaborators
- Herboplanet Srl
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Feb 2026 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| non-pharmacological therapy arm | Other | Dietary Supplement: Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plantafter 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Signing of informed consent
- 2. Diagnosis of Acute Coronary Syndrome (ACS)
- 3. Age 30-70
Key exclusion criteria (3 listed)
- Use in the three months preceding the signing of the informed consent of:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plantPatients will take 2 capsules/day of the product | Dietary supplement | non-pharmacological therapy arm |
Primary outcome
characterization of urinary metabolites
Time frame: through study completion, an average of 1 year
to assess the presence of dysmetabolisms
2 secondary outcomes
state of metabolic cardio risk
Time frame: through study completion, an average of 1 year
urinary dysmetabolism
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant in people with Acute Coronary Syndromes (ACS), run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterization of urinary metabolites (time frame: through study completion, an average of 1 year). 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 24 Feb 2026.