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Clinical Trials/NCT03863951
NCT03863951
Unknown
Not Applicable

The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country100 target enrollmentJanuary 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Enrollment
100
Locations
1
Primary Endpoint
The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis
Last Updated
7 years ago

Overview

Brief Summary

The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.

Detailed Description

In this study, patients with first ever acute ischemic stroke were studied. According to the psychological assessment, patients were divided into two groups according to whether or not there was a PSD at the earlier stage of stroke. Clinical biological data and blood and feces samples were collected. Firstly, 16srDNA sequencing was used to study the difference in the composition and diversity of intestinal microbial communities in the two groups of patients. Then the two groups selected individual representative samples and conducted macro genome sequencing. At the same time, by analyzing the correlation between the intestinal flora and the clinical risk factors and neurotransmitters in early PSD patients, the key functional bacteria related to PSD were identified.

Registry
clinicaltrials.gov
Start Date
January 20, 2019
End Date
February 28, 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • diagnosed with the first ever acute ischemic stroke occurring within 2 weeks and were confirmed by CT or MRI,
  • has no history of depression or use of antidepressants or antipsychotics,
  • were competent to consent to take part in this research.

Exclusion Criteria

  • significant acute or severe illness such as infection,heart failure and tumor,
  • previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics,
  • antibiotics in the last two weeks,
  • severe aphasia or dysarthria,irritable bowel syndrome,asthma,and pregnant or lactating women,
  • a previous history of neurological illness including AD and PD,
  • Inflammatory bowel disease,

Outcomes

Primary Outcomes

The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis

Time Frame: 2 weeks

Community diversity measured in the Shannon index

The Poststroke Depression Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score

Time Frame: 3 months

Mild depression(HAMD-17 Score\>7,≤17), moderate depression(HAMD-17 Score\>17,≤24), major depression(HAMD-17 Score\>24)

The Composition of Intestinal Microbial Communities Calculated by OTU Analysis

Time Frame: 2 weeks

The composition were measured in number based on OTU data

Functional Independence Assessed by Modified Rankin Scale (mRS)score

Time Frame: 3 months

MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score\>2), and death (mRS score = 6).

Secondary Outcomes

  • The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods(2 weeks)

Study Sites (1)

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