Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm (AneBiote)

Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm: a Comparison of Ruptured and Unruptured Patient With Taxonomic and Metabolic Evaluation of Microbiota

The physiopathology of intracranial aneurysm from initiation to ruptured is incompletely understood but included inflammation. The microbiota is known to interact with brain and can promote inflammation. The objective of this study is to describe microbiota with taxonomic and metabolomic analysis. A comparison between ruptured and unruptured intracranial aneurysm will be performed. The study hypothesis is that microbiota is different between ruptured and unruptured patient.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Sacciform Aneurysm
• Intervention / Treatment: Biological: analysis of foecal microbiota

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Dumot Chloé, Dr PhD; Phone Number: +334 72355839; Email: chloe.dumot@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult patients with ruptured aneurysm and unruptured aneurysm

Description

Inclusion Criteria:

• one or more intracranial sacciform aneurysm ruptured or not in function of the inclusion group

Exclusion Criteria:

• Transient modification of microbiota: Antibiotherapy in the last 3 months, pre or probiotic in the last month, gastrostomy, ileostomy, bariatric surgery, digestive tract resection, gastro-duodenal ulcer surgery or during the last month, chronic inflammatory disease of the digestive tract (like Crohn), BMI for more than 30, Very restrictive diet (like vegan
• Specific pathologies increasing the incidence of aneurysm ( kidney autosomic dominant polycystosis, Type 1 neurofibromatosis, Rendu-Osler, MArfan
• Participation to a study with the objective of microbiota modification

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ruptured; Patient with a ruptured intracranial sacciform aneurysm for all location. The diagnosis of ruptured aneurysm is made on MRI, Angio-CT or digital substraction angiography with no doubt	Biological: analysis of foecal microbiota; An analysis of foecal microbiota including taxonomic and metabolomic analysis will be performed and compared between ruptured and unruptured patient. confundens factors as diet, obesity for microbiota and as smoking, hypertension, size for aneurysm ruptured will be sampled and independence will be analyzed.
unruptured; Patient with an unruptured intracranial sacciform aneurysm for all location. The diagnosis of unuptured aneurysm is made on MRI, Angio-CT or digital substraction angiography with no doubt	Biological: analysis of foecal microbiota; An analysis of foecal microbiota including taxonomic and metabolomic analysis will be performed and compared between ruptured and unruptured patient. confundens factors as diet, obesity for microbiota and as smoking, hypertension, size for aneurysm ruptured will be sampled and independence will be analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Taxonomic faecal microbiota description	The results of the taxonomic analysis of fecal samples will be described in the two groups. Interesting parameter will be selected for further analysis	The faecal samples will be taken at 3 days+/-2 after the ruptured and during the arteriography for the unruptured group within 3 months after inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Dumot Chloé, Dr PhD, Hôpital neurologique P. Wertheimer

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: risk factor; intestinal microbiota; Intracranial aneurysm; ruptured
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 69HCL21_0263; 2021-A02202-39 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No