Atheroscleroses, CoronarySYMBIO-ACSNCT07411287
Gut Microbiota Modulation With Synbiotics After Acute Coronary Syndrome
A study testing Pro-B (Bionaturis), and Guideline-Directed Medical Therapy (GDMT) in people with Atheroscleroses, Coronary and Microbiota, run by Centre Hospitalier de Bienne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atheroscleroses, Coronary, Microbiota
- What is being tested?
- Pro-B (Bionaturis), and Guideline-Directed Medical Therapy (GDMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gut Microbiota Modulation With Synbiotics as Secondary Prevention After Acute Coronary Syndrome: A Randomized-Controlled Trial Pilot Study
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.
Read the 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
- Being tested
- Pro-B (Bionaturis),, Guideline-Directed Medical Therapy (GDMT)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-B (Bionaturis),Dietary supplement
Also called Pro-B
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)
Guideline-Directed Medical Therapy (GDMT)Other
GDMT for Aacute coronary syndrome
| Study group | Role | What they receive |
|---|---|---|
| Symbiotic supplementation | Experimental | Supplementation with Pro-B (BioNaturis, Switzerland) for 10 weeks Receives: Dietary Supplement: Pro-B (Bionaturis),; Other: Guideline-Directed Medical Therapy (GDMT) |
| Control | Sham comparator | Standard guideline-directed medical therapy Receives: Other: Guideline-Directed Medical Therapy (GDMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMAO
TMAO level
Measured: At inclusion, 10 weeks and 1 year
Secondary outcomes (19)
Height
In meters
Measured: At inclusion, 10 weeks and 1 year
Weight
In kilograms
Measured: At inclusion, 10 weeks and 1 year
BMI
Combination of weight and height expressed as BMI (kg/m2), Weight (kg) /Height x Height (m)
Measured: At inclusion, 10 weeks and 1 year
Systolic Blood pressure
(mmHg), brachial
Measured: At inclusion, 10 weeks and 1 year
hsCRP
(mg/L)
Measured: At inclusion, 10 weeks and 1 year
HbA1c
Measured: At inclusion, 10 weeks and 1 year
SCFA and bile acids profile
(% variation)
Measured: At inclusion, 10 weeks and 1 year
LPS
(mg/L)
Measured: At inclusion, 10 weeks and 1 year
Lipid profile (LDL, High total/HDL-cholesterol and LDL/HDL-cholesterol)
mg/dl or ratio
Measured: At inclusion, 10 weeks and 1 year
Malondialdehyde
(µmol/L)
Measured: At inclusion, 10 weeks and 1 year
Total antioxidant capacity
(mmol/L)
Measured: At inclusion, 10 weeks and 1 year
Imidazole propionate
(µmol/L)
Measured: At inclusion, 10 weeks and 1 year
Indoxyl Sulfate
(µmol/L)
Measured: At inclusion, 10 weeks and 1 year
Interleukins (IL1β, IL6, IL10)
pg/mL
Measured: At inclusion, 10 weeks and 1 year
IFN-γ
pg/mL
Measured: At inclusion, 10 weeks and 1 year
TNF-α
pg/mL
Measured: At inclusion, 10 weeks and 1 year
7-item Seattle Angina Questionnaire (SAQ-7)
7-item Seattle Angina Questionnaire (SAQ-7)
SAQ7: 0-100, where 100 is the best score (healthy cardiovascular state/absence of symptoms)
Measured: At inclusion, 10 weeks and 1 year
Clinical questionnaire
Adherence to ACS prescribed medication and study intervention, actual medication list, last antibiotics (if occurrence in the past year), unplanned emergency or medical consultations/hospitalizations, suspected side effects of intervention, gastrointestinal tolerance (focus on diarrhea/constipation, bloating, flatulence, nausea and abdominal pain/cramps), contact data of the patient and wish to be informed of the arm and the results at the end of the study.
No score, exploratory outcomes
Measured: At inclusion, 10 weeks and 1 year
Life's Essential 8 (LE8)
Life's Essential 8 (LE8) adaptated with Mediterranean Eating Pattern for Americans (MEPA)
LE8: 0-100, where 100 is the best score (healthy cardiovascular state/absence of symptoms). Exploratory diet outcomes
Measured: At inclusion, 10 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atheroscleroses, CoronaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Bienne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Schwab, Centre Hospitalier de Bienne
- Investigators
- Caroline Nguyen, PD, Study director, Centre Hospitalier de Bienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411287
- Sponsor's protocol ID
- BE202601
- Other IDs
- Ongoing
- Acronym
- SYMBIO-ACS
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant identified biomarkers that might impact research on other aspects of cardiovascular research
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Modulation With Synbiotics as Secondary Prevention After Acute Coronary Syndrome: A Randomized-Controlled Trial Pilot Study
- ClinicalTrials.gov ID
- NCT07411287
- Acronym / sponsor ID
- SYMBIO-ACS / BE202601
- Conditions
- Atheroscleroses, Coronary, Microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier de BienneUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Symbiotic supplementation | Experimental | Dietary Supplement: Pro-B (Bionaturis),, Other: Guideline-Directed Medical Therapy (GDMT)Supplementation with Pro-B (BioNaturis, Switzerland) for 10 weeks |
| Control | Sham comparator | Other: Guideline-Directed Medical Therapy (GDMT)Standard guideline-directed medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Mastering French or German or capacity to be helped with adequate translation
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-B (Bionaturis),Also: Pro-B10 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) | Dietary supplement | Symbiotic supplementation |
| Guideline-Directed Medical Therapy (GDMT)GDMT for Aacute coronary syndrome | Other | Control, Symbiotic supplementation |
Primary outcome
TMAO
Time frame: At inclusion, 10 weeks and 1 year
TMAO level
19 secondary outcomes
Height
Time frame: At inclusion, 10 weeks and 1 year
Weight
Time frame: At inclusion, 10 weeks and 1 year
BMI
Time frame: At inclusion, 10 weeks and 1 year
Systolic Blood pressure
Time frame: At inclusion, 10 weeks and 1 year
hsCRP
Time frame: At inclusion, 10 weeks and 1 year
HbA1c
Time frame: At inclusion, 10 weeks and 1 year
SCFA and bile acids profile
Time frame: At inclusion, 10 weeks and 1 year
LPS
Time frame: At inclusion, 10 weeks and 1 year
Lipid profile (LDL, High total/HDL-cholesterol and LDL/HDL-cholesterol)
Time frame: At inclusion, 10 weeks and 1 year
Malondialdehyde
Time frame: At inclusion, 10 weeks and 1 year
Total antioxidant capacity
Time frame: At inclusion, 10 weeks and 1 year
Imidazole propionate
Time frame: At inclusion, 10 weeks and 1 year
Indoxyl Sulfate
Time frame: At inclusion, 10 weeks and 1 year
Interleukins (IL1β, IL6, IL10)
Time frame: At inclusion, 10 weeks and 1 year
IFN-γ
Time frame: At inclusion, 10 weeks and 1 year
TNF-α
Time frame: At inclusion, 10 weeks and 1 year
7-item Seattle Angina Questionnaire (SAQ-7)
Time frame: At inclusion, 10 weeks and 1 year
Clinical questionnaire
Time frame: At inclusion, 10 weeks and 1 year
Life's Essential 8 (LE8)
Time frame: At inclusion, 10 weeks and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. Relevant identified biomarkers that might impact research on other aspects of cardiovascular research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Nguyen, PD study director
Centre Hospitalier de Bienne
Questions about this trial
What is this clinical trial studying?
A study testing Pro-B (Bionaturis), and Guideline-Directed Medical Therapy (GDMT) in people with Atheroscleroses, Coronary and Microbiota, run by Centre Hospitalier de Bienne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Schwab, MD (+41 32 324 48 77, symbioacs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMAO (time frame: At inclusion, 10 weeks and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.