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

Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551923
• Other study ID #: NFEC-2022-168
• Status: Recruiting
• Start date: August 14, 2020
• Est. completion date: April 2025

Study information

• Verified date: September 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: JIA YIN
• Phone: 13802964883
• Email: jiajiayin[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute
• Cerebral Hemorrhage
• Gut Microbiota
• Hemorrhage
• Hemorrhagic Stroke
• Metabolites
• Outcomes

Intervention

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

Locations

Country	Name	City	State
China	JIA YIN	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological function score (mRS score)	Neurological function score (mRS score)	3 months after onset
Primary	mortality	mortality	within 12 months after onset
Secondary	New cerebrovascular events	Occurrence of ischemic stroke and hemorrhagic stroke	within 12 months after onset
Secondary	NIHSS	NIHSS	The first day and the seventh day after admission, 3 months, 6 months and 12 months after onset
Secondary	Barthel Index	BI	3 months, 6 months and 12 months after onset
Secondary	Mini-mental State Examination	MMSE	The first day and the seventh day after admission, 3 months and 6 months after onset
Secondary	Montreal Cognitive Assessment	MOCA	The first day and the seventh day after admission?3 months and 6 months after onset