Gut Microbiota Modulation With Synbiotics After Acute Coronary Syndrome

NCT07411287 | Not Yet Recruiting

• 2 other identifiers: BE202601Ongoing
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atheroscleroses, Coronary; Microbiota

Outcome Measures

Primary Outcomes (1)

• TMAO

  TMAO level

  At inclusion, 10 weeks and 1 year

Secondary Outcomes (19)

• Height

  At inclusion, 10 weeks and 1 year

• Weight

  At inclusion, 10 weeks and 1 year

• BMI

  At inclusion, 10 weeks and 1 year

• Systolic Blood pressure

  At inclusion, 10 weeks and 1 year

• hsCRP

  At inclusion, 10 weeks and 1 year

Study Arms (2)

Symbiotic supplementation

EXPERIMENTAL

Supplementation with Pro-B (BioNaturis, Switzerland) for 10 weeks

Dietary Supplement: Pro-B (Bionaturis),; Other: Guideline-Directed Medical Therapy (GDMT)

Control

SHAM COMPARATOR

Standard guideline-directed medical therapy

Other: Guideline-Directed Medical Therapy (GDMT)

Interventions

Guideline-Directed Medical Therapy (GDMT) OTHER

GDMT for Aacute coronary syndrome

Control; Symbiotic supplementation

Pro-B (Bionaturis), DIETARY_SUPPLEMENT

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)

Also known as: Pro-B

Symbiotic supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Unstable angina: Myocardial ischaemia at rest or on minimal exertion in the absence of acute cardiomyocyte injury/necrosis. 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
• Type 1 myocardial infarction: Detection of a rise and/or 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
• Mastering French or German or capacity to be helped with adequate translation

You may not qualify if:

• 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.
• Ongoing pre/probiotic supplementation
• Chronic antibiotherapy or within less than 3 months
• Women who are pregnant or breast feeding
• Intention to become pregnant during the course of the study
• 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 / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential)
• Known or suspected non-compliance, drug or alcohol abuse, dement patients not living in assisted nurse facility care or without supervised treatment administration
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Sponsors & Collaborators

• Centre Hospitalier de Bienne: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Caroline Nguyen, PD

  Centre Hospitalier de Bienne

  STUDY DIRECTOR

Central Study Contacts

Johan Schwab, MD

CONTACT

+41 32 324 48 77; symbioacs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. MD, Clinical Lead

Model Details: RCT, no placebo which means unblinded. Being given the nature of the study (pilot project, monocentric, restricted budget), we chose not to administer placebo capsules in the control arm, because our primary endpoints are strictly biological and not subject to the placebo effect (no subjective measure and clinical outcomes assessed as secondary exploratory outcomes only). We are aware of the absence of placebo arm and blinding, and the consequent important influence of subjectivity in the assessment of clinical outcomes. In the context of the pilot nature of the study and the exploratory clinical outcomes, we however chose to include the scores in our study.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After completion of the study. Ne end date (unlimited time)
• Access Criteria: Data will be kept for our personal use or studies in our centers and/or upon request by other scientists.