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

NCT ID: NCT05551923

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2025-04-30

Brief 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 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.

Conditions

Hemorrhagic Stroke; Acute; Outcomes; Metabolites; Gut Microbiota

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute cerebral hemorrhage

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

intestinal flora disturbance

Intervention Type: OTHER

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

The group without stroke

The group without stroke

No interventions assigned to this group

Interventions

intestinal flora disturbance

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JIA YIN

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

JIA YIN

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

JIA YIN

Role: CONTACT

jiajiayin@139.com

13802964883

Facility Contacts

JIA YIN

Role: primary

jiajiayin@139.com

13802964883

Other Identifiers

NFEC-2022-168

Identifier Type: -

Identifier Source: org_study_id