Intracranial Sacciform AneurysmAneBioteNCT05914636
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
An observational study of Intracranial Sacciform Aneurysm, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Sacciform Aneurysm
- What is being tested?
- analysis of foecal microbiota
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2025to 28 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with ruptured aneurysm and unruptured aneurysm
Who may be able to join
- one or more intracranial sacciform aneurysm ruptured or not in function of the inclusion group
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital neurologique Pierre Wertheimer
Bron, 69500
Chloé DUMOT, MD, +33 4 72 35 78 44, chloe.dumot@chu-lyon.fr
Chloé DUMOT, MD
About this study
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
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.
- Conditions
- Intracranial Sacciform Aneurysm
- Being tested
- analysis of foecal microbiota
- Keywords
- Intracranial aneurysm, intestinal microbiota, risk factor, ruptured
- Medical subject headings
- Intracranial Aneurysm, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of foecal microbiotaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: analysis of foecal microbiota | |
| 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 Receives: Biological: analysis of foecal microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start28 Mar 2025
- Primary completion28 Jun 2029 (estimated)
- Study completion28 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Sacciform AneurysmStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dumot Chloé, Dr PhD, Principal investigator, Hôpital neurologique P. Wertheimer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914636
- Sponsor's protocol ID
- 69HCL21_0263
- Other IDs
- 2021-A02202-39
- Acronym
- AneBiote
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05914636
- Acronym / sponsor ID
- AneBiote / 69HCL21_0263
- Conditions
- Intracranial Sacciform Aneurysm
- Keywords
- Intracranial aneurysm, intestinal microbiota, risk factor, ruptured
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 Jun 2029 (estimated)
- Study completion
- 28 Jun 2029 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruptured | – | Biological: analysis of foecal microbiotaPatient 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 |
| unruptured | – | Biological: analysis of foecal microbiotaPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with ruptured aneurysm and unruptured aneurysm
Key inclusion criteria (1 listed)
- one or more intracranial sacciform aneurysm ruptured or not in function of the inclusion group
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of foecal microbiotaAn 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. | Biological | Ruptured, unruptured |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dumot Chloé, Dr PhD principal investigator
Hôpital neurologique P. Wertheimer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Sacciform Aneurysm, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dumot Chloé, Dr PhD (+33 4 72 35 78 44, chloe.dumot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.