Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Acute; Gut Microbiota; Metabolites; Hemorrhagic Stroke; Outcomes

Treatments: Other: intestinal flora disturbance

Study type: Observational

Funder types: Other

Identifiers

NCT05551923

NFEC-2022-168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. It meets the diagnostic criteria for acute ischemic stroke
2. Age ≥ 18 years
3. The onset time is less than or equal to 2 weeks
4. 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)
5. Sign an informed consent form, provide relevant medical history information and provide biological specimens

Exclusion criteria

1. Previous history of disabling stroke (pre-onset mRS ≥2)
2. Primary central nervous system tumor or hematologic system tumor
3. The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
4. Antibiotics, prebiotics/probiotics taken within 1 month
5. Patients who cannot have stool specimens within 4 days of admission

Trial design

300 participants in 2 patient groups

Acute cerebral hemorrhage

Description:

intestinal flora disturbance To observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder

Treatment:

Other: intestinal flora disturbance

The group without stroke

Description:

The group without stroke