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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhagic Stroke; Gut Microbiota; Outcomes; Acute; Metabolites
• Intervention / Treatment: Other: intestinal flora disturbance

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, Nanfang Hospital
      • Recruiting
      • JIA YIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Acute hemorrhagic stroke

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute cerebral hemorrhage; intestinal flora disturbance To observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder	Other: intestinal flora disturbance; To observe the clinical prognosis of acute cerebral hemorrhage after enterobacterial disorder
The group without stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological function score (mRS score)	Neurological function score (mRS score)	3 months after onset
mortality	mortality	within 12 months after onset

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2020
• Primary Completion (ANTICIPATED): April 1, 2025
• Study Completion (ANTICIPATED): April 1, 2025

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (ACTUAL): September 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hemorrhagic Stroke
• Other Study ID Numbers: NFEC-2022-168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No