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 range18 Years

SexALL

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
✕. Serious systemic diseases including malignant tumors
✕. Any antibiotics, probiotics or prebiotic treatment within 1 months

What they're measuring

The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score

Timeframe: 3 months

The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score

Timeframe: 6 months

The PSF Assessed by Fatigue Severity Scale（FSS）

Timeframe: 3 months

The PSF Assessed by Fatigue Severity Scale（FSS）

Timeframe: 6 months

Functional Independence Assessed by Modified Rankin Scale (mRS）score

Timeframe: 3 months

Functional Independence Assessed by Modified Rankin Scale (mRS）score

Timeframe: 6 months

Trial details

NCT IDNCT05414227

SponsorThe Affiliated Hospital of Xuzhou Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-28

Contact for this trial

Zhang Wei, Master

15162113531 neurodoc0708@126.com

View on ClinicalTrials.gov More Acute Ischemic Stroke trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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
✕. Serious systemic diseases including malignant tumors
✕. Any antibiotics, probiotics or prebiotic treatment within 1 months

What they're measuring

The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score

Timeframe: 3 months

The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score

Timeframe: 6 months

The PSF Assessed by Fatigue Severity Scale（FSS）

Timeframe: 3 months

The PSF Assessed by Fatigue Severity Scale（FSS）

Timeframe: 6 months

Functional Independence Assessed by Modified Rankin Scale (mRS）score

Timeframe: 3 months

Functional Independence Assessed by Modified Rankin Scale (mRS）score

Timeframe: 6 months