Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 1:45 AM
Study NCT ID:
NCT07429227
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054769', 'term': 'G-Protein-Coupled Receptor Kinase 2'}], 'ancestors': [{'id': 'D051552', 'term': 'beta-Adrenergic Receptor Kinases'}, {'id': 'D054768', 'term': 'G-Protein-Coupled Receptor Kinases'}, {'id': 'D017346', 'term': 'Protein Serine-Threonine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'characterization of urinary metabolites', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'to assess the presence of dysmetabolisms'}], 'secondaryOutcomes': [{'measure': 'state of metabolic cardio risk', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'picture of all the pro-atherogenic factors'}, {'measure': 'urinary dysmetabolism', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'interaction of non-pharmacological therapy and urinary dysmetabolisms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intestinal permeability', 'unstable coronary artery disease', 'acute myocardial infarction', 'metabolomic', 'essential oils', 'dietary supplement', 'dysbiosis'], 'conditions': ['Acute Coronary Syndromes (ACS)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAfter 6 hours from the T0 visit, a second urine collection will be performed as per clinical practice (two samples per subject).\n\nAfter 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).\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Signing of informed consent\n* 2\\. Diagnosis of Acute Coronary Syndrome (ACS)\n* 3\\. Age 30-70\n\nExclusion Criteria:\n\n1. Use in the three months preceding the signing of the informed consent of:\n\n 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\n2. 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.'}, 'identificationModule': {'nctId': 'NCT07429227', 'acronym': 'DISBIO', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Casa di Cura Dott. Pederzoli'}, 'officialTitle': 'Metabolomic and Cellular Inflammaging Investigation Study of Patients With Acute Coronary Syndrome (ACS)', 'orgStudyIdInfo': {'id': '748CET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'non-pharmacological therapy arm', 'description': 'after discharge from the experimental center the subject will be prescribed drug therapy, as directed by the medical experimenter, and non-drug therapy.\n\nFor 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.', 'interventionNames': ['Dietary Supplement: Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant']}], 'interventions': [{'name': 'Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will take 2 capsules/day of the product', 'armGroupLabels': ['non-pharmacological therapy arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37019', 'city': 'Peschiera del Garda', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Fusco, MD', 'role': 'CONTACT', 'email': 'urc@ospedalepederzoli.it', 'phone': '+39 0456444193'}], 'facility': 'Ospedale P. Pederzoli Casa di Cura Privata S.p.A.', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa di Cura Dott. Pederzoli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herboplanet Srl', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}