Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: analysis of foecal microbiota.
- Who it may be relevant to
- Registry conditions: Intracranial Sacciform Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05914636 · 69HCL21_0263 · 2021-A02202-39