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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zhang Wei, Master; Phone Number: 15162113531; Email: neurodoc0708@126.com
• Study Contact Backup: Name: Hua Fang, PhD; Phone Number: 15252144898; Email: huafang@xzmc.edu.cn

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221002
      • Recruiting
      • The Affiliated Hospital Of XuZhou Medical University
      • Contact: Chen Renguo, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic stroke within 7 days of onset

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PSD; Depressed as assessed by the Hamilton Depression Scale 3 months after stroke
Non PSD; 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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Investigators: Study Chair: Chen Renguo, Master, The Affiliated Hospital Of XuZhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Prognosis; Acute Ischemic Stroke; Gut flora
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: XYFY2022-KL204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No