Clinical trial NCT05414227: The Association of Gut Microbes and Their Metabolites With Post-stroke Depression
Official title: Research on the Association of Gut Microbes and Their Metabolites With Post-stroke Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: Gut flora
Acute Ischemic Stroke
Prognosis
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke within 7 days of onset

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
timeFrame: 3 months
measure: The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
timeFrame: 6 months
measure: The PSF Assessed by Fatigue Severity Scale（FSS）
timeFrame: 3 months
measure: The PSF Assessed by Fatigue Severity Scale（FSS）
timeFrame: 6 months
measure: Functional Independence Assessed by Modified Rankin Scale (mRS）score
timeFrame: 3 months
measure: Functional Independence Assessed by Modified Rankin Scale (mRS）score
timeFrame: 6 months
Secondary outcomes:
measure: Gut microbial composition and diversity
timeFrame: First stool after admission
measure: Serum metabolites of gut microbiota
timeFrame: 7 days within stroke onset
measure: Serum inflammatory cytokines
timeFrame: 7 days within stroke onset
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Chen Renguo, Master
role: STUDY_CHAIR
References: