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

April 16, 2024 updated by: Hospices Civils de Lyon

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Dumot Chloé, Dr PhD, Hôpital neurologique P. Wertheimer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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