The Association of Gut Microbes and Their Metabolites With Post-stroke Depression (NCT05414227) | Clinical Trial Compass
UnknownNot Applicable
The Association of Gut Microbes and Their Metabolites With Post-stroke Depression
China200 participantsStarted 2022-06-06
Plain-language summary
In this study, the clinical data of patients with AIS were collected, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma，to explore the influence of gut microbiota and its metabolites on stroke prognosis.
Who can participate
Age range
18 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
. Patients who suffered from acute ischemic stroke
. Within 7 days of the onset
. Signing the informed consent, willing and able to attend all study visits
Exclusion criteria
. Severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate
. Previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics
. Gastrointestinal disease, and pregnant or lactating women
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 PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
Timeframe: 3 months
2
The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
Timeframe: 6 months
3
The PSF Assessed by Fatigue Severity Scale（FSS）
Timeframe: 3 months
4
The PSF Assessed by Fatigue Severity Scale（FSS）
Timeframe: 6 months
5
Functional Independence Assessed by Modified Rankin Scale (mRS）score
Timeframe: 3 months
6
Functional Independence Assessed by Modified Rankin Scale (mRS）score
Timeframe: 6 months
Trial details
NCT IDNCT05414227
SponsorThe Affiliated Hospital of Xuzhou Medical University