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

Coronary Disease Clinical Trial

— MABAC  

Official title:

The Official Title is in French: Microbiote, Acides Biliaires et Athérome Coronaire (MABAC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375893
• Other study ID #: 2014-A01643-44
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: December 15, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Other:
• No intervention
Collecting blood and feces samples
• Healthy subject
Collecting blood and feces samples

Locations

Country	Name	City	State
France	Cardiology Department, Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota composition in coronary patients versus healthy subject	Observational only	8 months	No
Secondary	Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples	Observational	8 months	No