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OpenTrials
Completed

NCT Number: NCT02375893

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Department, Cochin Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Collecting blood and feces samples

Healthy subject

Other

Collecting blood and feces samples

Primary outcomes

  1. Gut microbiota composition in coronary patients versus healthy subject

    Time frame: 8 months

    Observational only

Secondary outcomes

  1. Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples

    Time frame: 8 months

    Observational

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: MABAC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2015
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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