Gut Microbiota Modulation With Synbiotics After Acute Coronary Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Bienne
About this trial
Acute coronary syndrome (ACS) remains one of the leading causes of morbidity and mortality worldwide despite major advances in acute management and secondary prevention. Gut dysbiosis has been described as linked to cardiovascular events. Modulating the gut microbiota through symbiotics-a combination of probiotics and prebiotics-represents a promising, low-risk and widely accessible strategy to influence these pathways and contribute to the enhancement of cardiovascular prevention, with regards to the global burden as well as health costs.
The SYMBIO-ACS study is therefore designed to assess the effects of a symbiotic intervention on TMAO levels and identify new cardiometabolic biomarkers in patients following ACS, providing essential pilot data for future larger-scale preventive trials.
Eligibility criteria
Qualifiers
Informed Consent as documented by signature
Adult patients capable of providing discernment informed consent
Recent (< 1 week) diagnosis of acute coronary syndrome as defined in the last 2023 ESC guidelines and the Fourth universal definition of myocardial infarction, including unstable angina or myocardial infarction with or without ST-elevation, managed either with best guideline-directed medical therapy or percutaneous coronary intervention.
Myocardial injury: Elevated cardiac troponins (cTn) value above the 99th percentile URL. The injury is considered acute if there is a rise and/or fall of cTn values.
Disqualifiers
Contraindications to symbiotics as listed in Section 3.5.5, that is: immunocompromised individuals, intensive care patients (or critical state), severe valvulopathiesvalvular heart diseases, endocarditis antecedent, known allergy, chronic intestinal diseases or risk factors for small intestine bacterial overgrowth (SIBO) (severe malabsorption or history of digestive surgery), or severe comorbidities (see under)
Severe hepatic or renal dysfunction (defined as eGFR <30 mL/min/1,73 m², dialysis or Child-Pugh score class C)
Limited life expectancy (<1 year) or progressive malignant disease
Type 2 myocardial infarction: Detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL, and evidence of an imbalance between myocardial oxygen supply and demand unrelated to acute coronary athero-thrombosis, requiring at least one of the following: Symptoms of acute myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology.
Trial design
Treatments tested in this trial
- Pro-B (Bionaturis),
- Guideline-Directed Medical Therapy (GDMT)
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov