[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624565":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":32,"responsibleParty":43,"collaborators":32,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":32,"enrollmentInfo":57,"targetDuration":32,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":32,"overallStatus":67,"whyStopped":32,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":32},{"fullName":5,"class":6},"Centre Hospitalier de Bienne","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Symbiotic supplementation","EXPERIMENTAL","Supplementation with Pro-B (BioNaturis, Switzerland) for 10 weeks",[13,14],"Dietary Supplement: Pro-B (Bionaturis),","Other: Guideline-Directed Medical Therapy (GDMT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control","SHAM_COMPARATOR","Standard guideline-directed medical therapy",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Pro-B (Bionaturis),","10 weeks supplementation with Pro-B symbiotics (BioNaturis, Swizterland) 10 weeks supplementation with Pro-B Kaps, 9,6 x 109 CFU per day of Lactococcus lactis, Lactobacillus helveticus, Streptococcus thermophilus, Lactobacillus rhamnosus and Bifidobacterium longum plus 120 mg per day of fructooligosaccharides and vitamin B complex)",[9],[27],"Pro-B",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Guideline-Directed Medical Therapy (GDMT)","GDMT for Aacute coronary syndrome",[16,9],null,[34],{"name":35,"affiliation":5,"role":36},"Caroline Nguyen, PD","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Johan Schwab, MD","CONTACT","+41 32 324 48 77","symbioacs@gmail.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Johan Schwab","Dr. MD, Clinical Lead","100624565","gut-microbiota-modulation-with-synbiotics-after-acute-coronary-syndrome-100624565",false,"NCT07411287","Gut Microbiota Modulation With Synbiotics After Acute Coronary Syndrome","Gut Microbiota Modulation With Synbiotics as Secondary Prevention After Acute Coronary Syndrome: A Randomized-Controlled Trial Pilot Study","SYMBIO-ACS","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Adult patients capable of providing discernment informed consent\n* Recent (\\\u003C 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.\n\n  * Myocardial injury: Elevated cardiac troponins (cTn) value above the 99th percentile URL. The injury is considered acute if there is a rise and\u002For fall of cTn values.\n  * Unstable angina: Myocardial ischaemia at rest or on minimal exertion in the absence of acute cardiomyocyte injury\u002Fnecrosis. Prolonged (\\>20 min) angina at rest; new onset of severe angina; angina that is increasing in frequency, longer in duration, or lower in threshold; or angina that occurs after a recent episode of MI\n  * Type 1 myocardial infarction: Detection of a rise and\u002For fall of cTn values with at least one value above the 99th percentile URL and with at least one of the following: Symptoms of acute myocardial ischaemia; New ischaemic ECG change; 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;Identification of a coronary thrombus by angiography including intracoronary imaging or by autopsy\n* Mastering French or German or capacity to be helped with adequate translation\n\nExclusion Criteria:\n\n* 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)\n* Severe hepatic or renal dysfunction (defined as eGFR \\\u003C30 mL\u002Fmin\u002F1,73 m², dialysis or Child-Pugh score class C)\n* Limited life expectancy (\\\u003C1 year) or progressive malignant disease\n* Type 2 myocardial infarction: Detection of a rise and\u002For 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.\n* Ongoing pre\u002Fprobiotic supplementation\n* Chronic antibiotherapy or within less than 3 months\n* Women who are pregnant or breast feeding\n* Intention to become pregnant during the course of the study\n* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilised \u002F hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential)\n* Known or suspected non-compliance, drug or alcohol abuse, dement patients not living in assisted nurse facility care or without supervised treatment administration\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,\n* Previous enrolment into the current study,\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons","ALL","18 Years",{"count":58,"type":59},80,"ESTIMATED","INTERVENTIONAL",[62],"NA","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.\n\nThe 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.",[65,66],"Atheroscleroses, Coronary","Microbiota","NOT_YET_RECRUITING","2026-02-11",{"date":70,"type":71},"2026-02-13","ACTUAL",{"date":73,"type":59},"2026-06-01",{"date":75,"type":59},"2028-05-31",{"name":5,"class":6}]