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

Study Overview
=================
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.

Official Title
-----------------
Research on the Association of Gut Microbes and Their Metabolites With Post-stroke Depression

Conditions
-----------------
Acute Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSD<br>Depressed as assessed by the Hamilton Depression Scale 3 months after stroke | |
| Non PSD<br>Nondepressed as assessed by the Hamilton Depression Scale 3 months after stroke | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score | Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24） | 3 months | 
| The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score | Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24） | 6 months | 
| The PSF Assessed by Fatigue Severity Scale（FSS） | Fatigue（≥36） | 3 months | 
| The PSF Assessed by Fatigue Severity Scale（FSS） | Fatigue（FSS Score ≥36） | 6 months | 
| Functional Independence Assessed by Modified Rankin Scale (mRS）score | MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6) | 3 months | 
| Functional Independence Assessed by Modified Rankin Scale (mRS）score | MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbial composition and diversity | Results of fecal bacteria by 16s RNA sequencing | First stool after admission | 
| Serum metabolites of gut microbiota | Serum metabolites of gut microbiota from stool, detected by liquid chromatography-mass spectrometry (LC-MS) combined technique | 7 days within stroke onset | 
| Serum inflammatory cytokines | Inflammatory cytokines in blood，detected by flow cytometry | 7 days within stroke onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut flora, Acute Ischemic Stroke, Prognosis