Hemorrhagic StrokeNCT05551923
Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage
An observational study of Hemorrhagic Stroke and Acute, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Objective: To explore the predictive value of characteristic disorder of intestinal flora for clinical prognosis in patients with intracerebral hemorrhage. Secondary objectives: 1) To investigate the correlation of gut microbiota and its serological indicators with imaging features and clinical neurological deficits… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Stroke, Acute, Outcomes
- What is being tested?
- intestinal flora disturbance
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2020to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute hemorrhagic stroke
Who may be able to join
- It meets the diagnostic criteria for acute ischemic stroke
- Age ≥ 18 years
- The onset time is less than or equal to 2 weeks
- Diagnosis of cancer before stroke onset or during hospitalization and active cancer (failure to meet clinical criteria for cure, or discovery of recurrence or metastasis)
- Sign an informed consent form, provide relevant medical history information and provide biological specimens
Who cannot join
- Previous history of disabling stroke (pre-onset mRS ≥2)
- Primary central nervous system tumor or hematologic system tumor
- The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
- Antibiotics, prebiotics/probiotics taken within 1 month
- Patients who cannot have stool specimens within 4 days of admission
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
JIA YIN
Guangzhou, Guangdong, Nanfang Hospital
JIA YIN, 13802964883, jiajiayin@139.com
About this study
Objective: To explore the predictive value of characteristic disorder of intestinal flora for clinical prognosis in patients with intracerebral hemorrhage. Secondary objectives: 1) To investigate the correlation of gut microbiota and its serological indicators with imaging features and clinical neurological deficits in ICH; 2) Dynamically observe the changes of human microbiome and its serological indicators after ICH, and explore the biomarkers based on human microbiome related to disease changes.
Read the detailed description
Spontaneous intracerebral hemorrhage has brought a heavy burden to society and families. Finding biomarkers closely related to the condition of intracerebral hemorrhage is an important research direction for the prevention and treatment of intracerebral hemorrhage. However, there are few studies on the correlation between cerebral hemorrhage and microbiota. Our previous small sample study found that there were intestinal flora and SCFAs metabolism disorders in patients with hypertensive cerebral hemorrhage, and the latter was significantly related to poor prognosis. These results suggest that gut microbiota and its metabolites may become prognostic predictors and therapeutic targets for patients with intracerebral hemorrhage. However, more research evidence is still needed to confirm. Therefore, this study hypothesized that oral or intestinal flora in patients with acute cerebral hemorrhage has a certain degree of disorder and dynamic changes, accompanied by changes in serum markers, and there is a potential relationship between the changes of some microbiota-related markers and the severity and outcome of cerebral hemorrhage. Therefore, this topic proposed collection in patients with acute cerebral hemorrhage oral swabs, blood and feces or anal swab specimens, evaluate the neurological function score, imaging features and clinical outcomes, and to establish a follow-up queue, the dynamic change of cerebral hemorrhage patients after intestinal bacterial flora and condition and poor prognosis, the correlation of biomarkers new prediction and prevention of brain hemorrhage, To improve the effectiveness of prevention and treatment of cerebral hemorrhage.
- Conditions
- Hemorrhagic Stroke, Acute, Outcomes, Metabolites, Gut Microbiota
- Being tested
- intestinal flora disturbance
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intestinal flora disturbanceOther
To observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder
| Study group | Role | What they receive |
|---|---|---|
| Acute cerebral hemorrhage | intestinal flora disturbance To observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder Receives: Other: intestinal flora disturbance | |
| The group without stroke | The group without stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological function score (mRS score)
Neurological function score (mRS score)
Measured: 3 months after onset
mortality
mortality
Measured: within 12 months after onset
Secondary outcomes (5)
New cerebrovascular events
Occurrence of ischemic stroke and hemorrhagic stroke
Measured: within 12 months after onset
NIHSS
NIHSS
Measured: The first day and the seventh day after admission, 3 months, 6 months and 12 months after onset
Barthel Index
BI
Measured: 3 months, 6 months and 12 months after onset
Mini-mental State Examination
MMSE
Measured: The first day and the seventh day after admission, 3 months and 6 months after onset
Montreal Cognitive Assessment
MOCA
Measured: The first day and the seventh day after admission、3 months and 6 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start14 Aug 2020
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIA YIN, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551923
- Sponsor's protocol ID
- NFEC-2022-168
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05551923
- Acronym / sponsor ID
- NFEC-2022-168
- Conditions
- Hemorrhagic Stroke, Acute, Outcomes, Metabolites, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Sep 2022 (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.
Objective: To explore the predictive value of characteristic disorder of intestinal flora for clinical prognosis in patients with intracerebral hemorrhage. Secondary objectives: 1) To investigate the correlation of gut microbiota and its serological indicators with imaging features and clinical neurological deficits in ICH; 2) Dynamically observe the changes of human microbiome and its serological indicators after ICH, and explore the biomarkers based on human microbiome related to disease changes.
Detailed description
Spontaneous intracerebral hemorrhage has brought a heavy burden to society and families. Finding biomarkers closely related to the condition of intracerebral hemorrhage is an important research direction for the prevention and treatment of intracerebral hemorrhage. However, there are few studies on the correlation between cerebral hemorrhage and microbiota. Our previous small sample study found that there were intestinal flora and SCFAs metabolism disorders in patients with hypertensive cerebral hemorrhage, and the latter was significantly related to poor prognosis. These results suggest that gut microbiota and its metabolites may become prognostic predictors and therapeutic targets for patients with intracerebral hemorrhage. However, more research evidence is still needed to confirm. Therefore, this study hypothesized that oral or intestinal flora in patients with acute cerebral hemorrhage has a certain degree of disorder and dynamic changes, accompanied by changes in serum markers, and there is a potential relationship between the changes of some microbiota-related markers and the severity and outcome of cerebral hemorrhage. Therefore, this topic proposed collection in patients with acute cerebral hemorrhage oral swabs, blood and feces or anal swab specimens, evaluate the neurological function score, imaging features and clinical outcomes, and to establish a follow-up queue, the dynamic change of cerebral hemorrhage patients after intestinal bacterial flora and condition and poor prognosis, the correlation of biomarkers new prediction and prevention of brain hemorrhage, To improve the effectiveness of prevention and treatment of cerebral hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute cerebral hemorrhage | – | Other: intestinal flora disturbanceintestinal flora disturbance To observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder |
| The group without stroke | – | –The group without stroke |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute hemorrhagic stroke
Key inclusion criteria (5 listed)
- It meets the diagnostic criteria for acute ischemic stroke
- Age ≥ 18 years
- The onset time is less than or equal to 2 weeks
- Diagnosis of cancer before stroke onset or during hospitalization and active cancer (failure to meet clinical criteria for cure, or discovery of recurrence or metastasis)
- Sign an informed consent form, provide relevant medical history information and provide biological specimens
Key exclusion criteria (5 listed)
- Previous history of disabling stroke (pre-onset mRS ≥2)
- Primary central nervous system tumor or hematologic system tumor
- The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
- Antibiotics, prebiotics/probiotics taken within 1 month
- Patients who cannot have stool specimens within 4 days of admission
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 |
|---|---|---|
| intestinal flora disturbanceTo observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder | Other | Acute cerebral hemorrhage |
Primary outcome
Neurological function score (mRS score)
Time frame: 3 months after onset
Neurological function score (mRS score)
mortality
Time frame: within 12 months after onset
mortality
5 secondary outcomes
New cerebrovascular events
Time frame: within 12 months after onset
NIHSS
Time frame: The first day and the seventh day after admission, 3 months, 6 months and 12 months after onset
Barthel Index
Time frame: 3 months, 6 months and 12 months after onset
Mini-mental State Examination
Time frame: The first day and the seventh day after admission, 3 months and 6 months after onset
Montreal Cognitive Assessment
Time frame: The first day and the seventh day after admission、3 months and 6 months after onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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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. This study is not recruiting at the moment.
JIA YIN study chair
Nanfang Hospital, Southern Medical University
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 Hemorrhagic Stroke and Acute, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIA YIN (13802964883, jiajiayin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological function score (mRS score) (time frame: 3 months after onset). The study lists 2 primary outcomes in all. 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 23 Sep 2022.