Clinical trial NCT03863951: Poststroke Depression of Clinical Trial Registration
Official title: The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Depression
Keywords: ischemic stroke
depression
intestinal microbiota
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute ischemic stroke patients

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.

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，

Primary outcomes:
measure: The Composition of Intestinal Microbial Communities Calculated by OTU Analysis
timeFrame: 2 weeks
measure: The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis
timeFrame: 2 weeks
measure: The Poststroke Depression Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
timeFrame: 3 months
measure: Functional Independence Assessed by Modified Rankin Scale (mRS）score
timeFrame: 3 months
Secondary outcomes:
measure: The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Yurong Zhang
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yurong Zhang, PhD
role: STUDY_CHAIR
References: