Clinical trial NCT05551923: Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage
Official title: Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhagic Stroke
Acute
Outcomes
Metabolites
Gut Microbiota
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute hemorrhagic stroke

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.

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

Primary outcomes:
measure: Neurological function score (mRS score)
timeFrame: 3 months after onset
measure: mortality
timeFrame: within 12 months after onset
Secondary outcomes:
measure: New cerebrovascular events
timeFrame: within 12 months after onset
measure: NIHSS
timeFrame: The first day and the seventh day after admission, 3 months, 6 months and 12 months after onset
measure: Barthel Index
timeFrame: 3 months, 6 months and 12 months after onset
measure: Mini-mental State Examination
timeFrame: The first day and the seventh day after admission, 3 months and 6 months after onset
measure: Montreal Cognitive Assessment
timeFrame: The first day and the seventh day after admission、3 months and 6 months after onset
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: JIA YIN
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: JIA YIN
role: STUDY_CHAIR
References: