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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05551923
Enrollment
300
Registered
2022-09-23
Start date
2020-08-14
Completion date
2025-04-30
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute, Gut Microbiota, Hemorrhagic Stroke, Metabolites, Outcomes

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.

Interventions

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

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neurological function score (mRS score)3 months after onsetNeurological function score (mRS score)
mortalitywithin 12 months after onsetmortality

Secondary

MeasureTime frameDescription
Barthel Index3 months, 6 months and 12 months after onsetBI
New cerebrovascular eventswithin 12 months after onsetOccurrence of ischemic stroke and hemorrhagic stroke
Montreal Cognitive AssessmentThe first day and the seventh day after admission、3 months and 6 months after onsetMOCA
Mini-mental State ExaminationThe first day and the seventh day after admission, 3 months and 6 months after onsetMMSE
NIHSSThe first day and the seventh day after admission, 3 months, 6 months and 12 months after onsetNIHSS

Countries

China

Contacts

Primary ContactJIA YIN
jiajiayin@139.com13802964883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026