Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study

NCT06379464 | Unknown

• 1 other identifier: CALM2303
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives of Study： Through the cross-sectional study of stroke and depression, key biomarkers are targeted by screening disease-associated intestinal bacteria, metabolites and immune factors through multi-omics techniques.

Conditions

Acute Ischaemic Stroke; Depression

Outcome Measures

Primary Outcomes (3)

• The severity of neurological damage in stroke patients

  The severity of neurological damage in stroke patient evaluated by National Institutes of Health Stroke Scale(NHISS), the scoring range is 0-42 points, with higher scores indicating more severe neurological damage.

  The evaluation will be conducted on the second day after admission

• The functional recovery outcomes after stroke

  The functional recovery outcomes after stroke evaluated by Modified Rankin Scale(mRS), the scoring range is 0-6 points, with higher scores indicating worse functional outcome.

  The evaluation will be conducted at 3 months after admission

• The severity of symptoms in patients with depression

  The severity of symptoms in patients with depression is evaluated by Hamilton Depression Scale(HAMD), the scoring range is 0-54 points, with higher scores indicating more severe depressive states.

  The evaluation will be conducted on the second day after admission

Study Arms (2)

Patients with acute ischaemic stroke

Patients who met the diagnostic criteria of the 2018 Chinese guidelines for the diagnosis and treatment of acute ischemic stroke.

Depressed patients

Patients who met the depression related criteria in the Chinese classification and diagnostic criteria for mental disorders.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with acute ischaemic stroke； 2. Depressed patients

You may qualify if:

• Age range from 18 to 90 years old;
• Patients who met the diagnostic criteria of the 2018 Chinese guidelines for the diagnosis and treatment of acute ischemic stroke;
• Sign the informed consent form, provide relevant medical history information and provide blood, urine and stool samples.

You may not qualify if:

• Serious systemic diseases including malignancies;
• Alanine aminotransferase or aspartate aminotransferase \>2 times the upper limit of normal value or severe liver disease;
• Creatinine \>1.5 times the upper limit of normal or severe nephropathy;
• A long-term history of drinking, drug taking and chemical poisoning. A long-term history of drinking refers to a history of more than 5 years, equivalent to alcohol \>40g/d for men and 20g/d for women, or a history of heavy drinking within 2 weeks, equivalent to alcohol \>80g/d;
• Those with previous history of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or diagnosed in Hospital;
• Unable to retain the required samples.
• Depressed patients:
• Age range from 18 to 90 years old;
• Patients who met the depression related criteria in the Chinese classification and diagnostic criteria for mental disorders;
• Sign the informed consent form, provide relevant medical history information and provide oral swabs, blood, urine and stool samples.
• Serious systemic diseases including malignancies;
• Alanine aminotransferase or aspartate aminotransferase \>2 times the upper limit of normal value or severe liver disease;
• Creatinine \>1.5 times the upper limit of normal or severe nephropathy;
• A long-term history of drinking, drug taking and chemical poisoning. A long-term history of drinking refers to a history of more than 5 years, equivalent to alcohol \>40g/d for men and 20g/d for women, or a history of heavy drinking within 2 weeks, equivalent to alcohol \>80g/d;
• Those with previous history of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or diagnosed in Hospital;

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, 510145, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, mouth swab

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Hongwei Zhou

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Kaiyu XU

CONTACT

13590349187; 1500810165@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 23, 2024
• Study Start: September 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 23, 2024

Record last verified: 2023-08

Locations

CN (1)