Bile Acids and Gut Microbiota as Potent Coronary Atheroma... | NCT02375893

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

NCT02375893

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Coronary Disease

Interventions

No intervention
Healthy subject

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 24, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Collecting blood and feces samples	Coronary patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gut microbiota composition in coronary patients versus healthy subject	Observational only	8 months

Secondary Outcomes

Measure	Description	Time Frame
Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples	Observational	8 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Tertiary care center: cardiology unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Denis Duboc, MD, PhD	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology Department, Cochin Hospital		Paris		75014	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34811445	Result	Chong Nguyen C, Duboc D, Rainteau D, Sokol H, Humbert L, Seksik P, Bellino A, Abdoul H, Bouazza N, Treluyer JM, Saadi M, Wahbi K, Soliman H, Coffin B, Bado A, Le Gall M, Varenne O, Duboc H. Circulating bile acids concentration is predictive of coronary artery disease in human. Sci Rep. 2021 Nov 22;11(1):22661. doi: 10.1038/s41598-021-02144-y.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D003327	Coronary Disease
D050197	Atherosclerosis