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

NCT05551923 | Unknown

• 1 other identifier: NFEC-2022-168
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Stroke; Acute; Outcomes; Metabolites; Gut Microbiota

Outcome Measures

Primary Outcomes (2)

• Neurological function score (mRS score)

  Neurological function score (mRS score)

  3 months after onset

• mortality

  mortality

  within 12 months after onset

Secondary Outcomes (5)

• New cerebrovascular events

  within 12 months after onset

• NIHSS

  The first day and the seventh day after admission, 3 months, 6 months and 12 months after onset

• Barthel Index

  3 months, 6 months and 12 months after onset

• Mini-mental State Examination

  The first day and the seventh day after admission, 3 months and 6 months after onset

• Montreal Cognitive Assessment

  The first day and the seventh day after admission、3 months and 6 months after onset

Study Arms (2)

Acute cerebral hemorrhage

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

Other: intestinal flora disturbance

The group without stroke

The group without stroke

Interventions

intestinal flora disturbance OTHER

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

Acute cerebral hemorrhage

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute hemorrhagic stroke

You may qualify if:

• It meets the diagnostic criteria for acute ischemic stroke
• Age ≥ 18 years
• The onset time is less than or equal to 2 weeks
• 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)
• Sign an informed consent form, provide relevant medical history information and provide biological specimens

You may not qualify if:

• Previous history of disabling stroke (pre-onset mRS ≥2)
• Primary central nervous system tumor or hematologic system tumor
• The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
• Antibiotics, prebiotics/probiotics taken within 1 month
• Patients who cannot have stool specimens within 4 days of admission

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

JIA YIN

Guangzhou, Guangdong, Nanfang Hospital, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, oral swabs

MeSH Terms

Conditions

Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• JIA YIN

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

JIA YIN

CONTACT

13802964883; jiajiayin@139.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 23, 2022
• Study Start: August 14, 2020
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

CN (1)