Identifying gut bacteria markers in stroke and depression

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

This study is trying to find out if certain gut bacteria are linked to stroke and depression by looking at samples from people who have these conditions.

Quick facts

• Study type: Observational
• Enrollment: 320 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT06379464 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between gut microbiota and the conditions of acute ischemic stroke and depression. By utilizing multi-omics techniques, the study will screen for disease-associated intestinal bacteria, metabolites, and immune factors. The research is motivated by the increasing burden of cerebrovascular diseases and mental illnesses in China, with a focus on uncovering reliable biological markers for diagnosis. Participants will provide blood, urine, and stool samples to facilitate this investigation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 90 who have been diagnosed with acute ischemic stroke.

Not a fit: Patients with serious systemic diseases, severe liver or kidney conditions, or a history of intestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the identification of new biomarkers for diagnosing and treating stroke and depression.

How similar studies have performed: While the approach of investigating gut microbiota in relation to neurological and psychiatric conditions is gaining traction, this specific study's methodology is relatively novel and untested.

Eligibility criteria

AIS Patients:

Inclusion Criteria:

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

Exclusion Criteria:

1. Serious systemic diseases including malignancies;
2. Alanine aminotransferase or aspartate aminotransferase \>2 times the upper limit of normal value or severe liver disease;
3. Creatinine \>1.5 times the upper limit of normal or severe nephropathy;
4. 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;
5. Those with previous history of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or diagnosed in Hospital;
6. Unable to retain the required samples.

Depressed patients:

Inclusion Criteria:

1. Age range from 18 to 90 years old;
2. Patients who met the depression related criteria in the Chinese classification and diagnostic criteria for mental disorders;
3. Sign the informed consent form, provide relevant medical history information and provide oral swabs, blood, urine and stool samples.

Exclusion Criteria:

1. Serious systemic diseases including malignancies;
2. Alanine aminotransferase or aspartate aminotransferase \>2 times the upper limit of normal value or severe liver disease;
3. Creatinine \>1.5 times the upper limit of normal or severe nephropathy;
4. 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;
5. Those with previous history of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or diagnosed in Hospital;
6. Unable to retain the required samples.

Where this trial is running

Guanzhou, Guangdong

• Zhujiang Hospital of Southern Medical University — Guanzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Kaiyu XU

Conditions Acute Ischaemic Stroke; Depression