The Association of Gut Microbes and Their Metabolites With Post-stroke Depression

Xuzhou Medical University

Status: Enrolling

Conditions: Acute Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT05414227

XYFY2022-KL204

Details and patient eligibility

About

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.

Full description

In recent years, more and more studies have been conducted on the gut-brain axis, and gut microbes can affect the brain by regulating immune responses, metabolites, and neurotransmitters. The composition of gut microbiota may affect stroke prognosis, including focal neurological deficits, cognitive impairment, anxiety and depression, and fatigue. In this study, 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. The clinical data of patients were collected, including age, gender, and medical history, NIHSS, mRS, MMSE, Patient Health Questionnaire-9（PHQ9）, Social Support Rating Scale（SSRS）, laboratory and radiology results. The neurological recovery of the patients was assessed after 3 and 6 months, and the presence or absence of post-stroke depression（PSD） and post-stroke fatigue（PSF） was assessed by the Hamilton Depression Scale, the Fatigue Severity Scale（FSS） and the Multidimensional Fatigue Scale（MFS）. To evaluate the relationship between gut microbiota and its metabolites and stroke prognosis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who suffered from acute ischemic stroke
2. Within 7 days of the onset
3. Signing the informed consent, willing and able to attend all study visits

Exclusion criteria

1. Severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate
2. Previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics
3. Gastrointestinal disease, and pregnant or lactating women
4. Serious systemic diseases including malignant tumors
5. Any antibiotics, probiotics or prebiotic treatment within 1 months

Trial design

200 participants in 2 patient groups

PSD

Description:

Depressed as assessed by the Hamilton Depression Scale 3 months after stroke

Non PSD

Description:

Nondepressed as assessed by the Hamilton Depression Scale 3 months after stroke