AneBiote: Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05914636

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Sacciform Aneurysm	Biological: analysis of foecal microbiota

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Taxonomic faecal microbiota description [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]
The results of the taxonomic analysis of fecal samples will be described in the two groups. Interesting parameter will be selected for further analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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