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

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT05414227
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

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.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-06
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Study First Posted: 2022-06-10
• Last Update Posted: 2022-06-10
• Primary Completion: 2023-02-28
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China