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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Centre Hospitalier de Bienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Symbiotics may reduce TMAO levels, decrease systemic inflammation, and support metabolic regulation. However, evidence in post-ACS patients remains limited, and controlled clinical trials addressing mechanistic biomarkers are needed. 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. The aim of the study is to detect a 50% TMAO reduction (and a difference of 1 to 2 μmol/L) with gut modulation with symbiotics after acute coronary syndrome, and identify other relevant anthropometric and biomarkers Design: Prospective monocentric randomized-control trial with superiority design. Population: Outpatient cardiology clinic or emergency department of the hospital of Biel in Switzerland. Protocol: Patients diagnosed with an ACS (less than one week ago) will be identified by doctors of the cardiology department of the Biel Spital Zentrum (Switzerland) both in the ambulatory consultation and emergency department, where cardiologist act as consultants. They will be informed on the study and if wished be given a 48 hours reflection before agreeing with the consent form. All patients, regardless of our study, will be offered the best-guideline directed medical therapy (according to either performed PCI or conservative treatment) with implantation of lifestyle measures (advice with brochure on the Mediterranean diet, physical activity, and tobacco cessation). Then, they will be randomized 1:1 with a software (stratification for age, sex, vegetarian diet and cardiovascular risk factors (cardiovascular risk factors (hypertension, mellitus diabetes, dyslipidemia)) to receive a 10 week daily symbiotic supplementation or the standard therapy alone (no placebo). At maximum one week after diagnosis of ACS, patients in the intervention group will be provided with the adequate number of capsules for the duration of the study (2 per day, for 10 weeks, giving 140 capsules per patient) with clear instructions. All included patients will as well be given a study ID number, the anonymization is guaranteed. Assessement(demographics, anthropometric and laboratory, questionnaire) will be directly asked by the investigators or found in the medical record of the patient. For all the required analysis in addition to the routine laboratory parameters, a sample 2 x 5ml of native blood is planned as supplement to routine analysis. These supplementary analyses will be undergone in a specialized extern laboratory in Inselspital the department of biomedical research linked to Inselspital (University of Bern, CH). The same measures (anthropometric and plasmatic) will be routinely repeated after 10 weeks of intervention and retrieved in the patient medical record, and again at one year, still in the context of usual follow-up appointments. A questionnaire will be given as well at inclusion, 10 weeks and 1 year (Redcap link send per mail/post in case of outpatient care setting, or under paper form if wished by the patient or better suited because lack of internet access). The 7-item Seattle Angina Questionnaire (SAQ-7) and the Life's Essential 8 (LE8) are planned to be used. Statistics: 80 patients (40 per arm). Number of patients required to obtain a 50% reduction in TMAO levels and a 1 to 2 μmol/L difference (classic formula for calculating the sample size for a comparison of means between two groups (two-tailed test, α = 0.05, power = 90%), and estimated baseline of 5-6 μmol/L and a standard deviation of 2,0 to 2,5 μmol/L in post-ACS, considering a compensation for 10% foreseen losses. Primary between-group comparison of change in plasma TMAO levels using an analysis of covariance (ANCOVA) model adjusted for baseline TMAO and relevant covariates (age, sex, renal function, vegetarian diet and cardiovascular risk factors (hypertension, mellitus diabetes, dyslipidemia)). Secondary and exploratory outcomes, including inflammatory markers

Conditions

• Atheroscleroses, Coronary
• Microbiota

Interventions

Type	Name	Description
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)
OTHER	Guideline-Directed Medical Therapy (GDMT)	GDMT for Aacute coronary syndrome

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2026-02-13
• Last updated: 2026-02-13