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

NCT ID: NCT05414227

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2023-05-31

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.

Conditions

Acute Ischemic Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PSD

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

No interventions assigned to this group

Non PSD

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen Renguo, Master

Role: STUDY_CHAIR

The Affiliated Hospital of Xuzhou Medical University

Locations

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang Wei, Master

Role: CONTACT

neurodoc0708@126.com

15162113531

Hua Fang, PhD

Role: CONTACT

huafang@xzmc.edu.cn

15252144898

Facility Contacts

Chen Renguo, Master

Role: primary

Other Identifiers

XYFY2022-KL204

Identifier Type: -

Identifier Source: org_study_id