Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study (NCT06379464) | Clinical Trial Compass
UnknownNot Applicable
Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study
China320 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The severity of neurological damage in stroke patients
Timeframe: The evaluation will be conducted on the second day after admission
2
The functional recovery outcomes after stroke
Timeframe: The evaluation will be conducted at 3 months after admission
3
The severity of symptoms in patients with depression
Timeframe: The evaluation will be conducted on the second day after admission