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

Recruiting

• Conditions: Gut Microbiota; Acute; Metabolites; Hemorrhagic Stroke; Outcomes
• Interventions: Other: intestinal flora disturbance

• Registration Number: NCT05551923
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2020-08-14
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute cerebral hemorrhage	intestinal flora disturbance	intestinal flora disturbance To observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder

Primary Outcome Measures

Name	Time	Method
Neurological function score (mRS score)	3 months after onset	Neurological function score (mRS score)
mortality	within 12 months after onset	mortality

Secondary Outcome Measures

Name	Time	Method
New cerebrovascular events	within 12 months after onset	Occurrence of ischemic stroke and hemorrhagic stroke
NIHSS	The first day and the seventh day after admission, 3 months, 6 months and 12 months after onset	NIHSS
Montreal Cognitive Assessment	The first day and the seventh day after admission、3 months and 6 months after onset	MOCA
Barthel Index	3 months, 6 months and 12 months after onset	BI
Mini-mental State Examination	The first day and the seventh day after admission, 3 months and 6 months after onset	MMSE

Trial Locations

Locations (1)

JIA YIN; 🇨🇳 Guangzhou, Guangdong, China