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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414227
• Other study ID #: XYFY2022-KL204
• Status: Recruiting
• Start date: June 6, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2022
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: Zhang Wei, Master
• Phone: 15162113531
• Email: neurodoc0708[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The PSF Assessed by Fatigue Severity Scale(FSS)	Fatigue(=36)	3 months
Primary	The PSF Assessed by Fatigue Severity Scale(FSS)	Fatigue(FSS Score =36)	6 months
Primary	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
Primary	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	Gut microbial composition and diversity	Results of fecal bacteria by 16s RNA sequencing	First stool after admission
Secondary	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
Secondary	Serum inflammatory cytokines	Inflammatory cytokines in blood,detected by flow cytometry	7 days within stroke onset