Bile Acids and Gut Microbiota as Potent Coronary Atheroma Risk Factors: a Prospective Study in Human (MABAC)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Coronary Disease

Treatments: Other: No intervention; Other: Healthy subject

Study type: Observational

Funder types: Other

Identifiers

NCT02375893

2014-A01643-44

Details and patient eligibility

About

The purpose of this study is to describe the composition of bile acids and the gut microbiota comparing two populations: patients with coronary atheroma and the healthy subjects.

Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.

Full description

Atherosclerosis is the main cause of cardiovascular diseases which remain the first cause of death worldwide. The prevention of risk factors can reduce the development of cardiovascular diseases. The final goal of our study is to find new protective or new risk factors that can be modulated to reduce the incidence of cardiovascular events.

Gut microbiota and its main metabolite, the bile acids, are implicated in the metabolic regulation. Some bile acids, especially the secondary bile acids, transformed from the primary bile acids by the bacteria of the gut microbiota, are now demonstrated in murine experimental atherosclerosis models, to be anti inflammatory and anti atherogenic molecules.

We want to compare the pool of bile acids and the composition of gut microbiota between the coronary patients and the healthy subjects to identify the potential protective or deleterious bacteria / bile acids.

All patients admitted for a scheduled coronary angiogram will be included, then divided into two groups: coronary or healthy, based on the presence or the absence of atheroma during the coronary angiogram.

Feces and blood samples, and clinical and biological data, will be collected during the patient's hospitalisation. No additional exam will be performed. The blood sample will be collected during the coronary angiogram or during a routine blood test.

Enrollment: 80 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- All patients admitted for a coronary angiogram

Exclusion criteria

• Statins, hypolipemic drugs, corticoids, anti HIV drugs
• Antibiotics adminisitration in the last 3 months
• Past of cholecystectomy
• Hepatic disorders
• Acute coronary syndrome
• No agreement, Insufficiency in comprehension
• Non fasting for at least 8 hours

Trial design

80 participants in 2 patient groups

Coronary patients

Description:

Feces, blood sample, clinical and biological data. Presence (1) of coronary disease defined as the presence of atheroma during the coronary angiogram

Treatment:

Other: No intervention

Healthy subjects (2)

Description:

Feces, blood sample, clinical and biological data. Absence (2) of atheroma during the coronary angiogram

Treatment:

Other: Healthy subject