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

Completed

• Conditions: Coronary Disease
• Interventions: Other: No intervention; Other: Healthy subject

• Registration Number: NCT02375893
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary patients	No intervention	Feces, blood sample, clinical and biological data. Presence (1) of coronary disease defined as the presence of atheroma during the coronary angiogram
Healthy subjects (2)	Healthy subject	Feces, blood sample, clinical and biological data. Absence (2) of atheroma during the coronary angiogram

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition in coronary patients versus healthy subject	8 months	Observational only

Secondary Outcome Measures

Name	Time	Method
Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples	8 months	Observational

Trial Locations

Locations (1)

Cardiology Department, Cochin Hospital; 🇫🇷 Paris, France