Poststroke Depression of Clinical Trial Registration (IFEPSDAIS)

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

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

Study Overview

• Status: Unknown
• Conditions: Depression; Stroke

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Yurong Zhang
      • Contact: Yurong Zhang; Email: zhangyurong72@mail.xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

acute ischemic stroke patients

Description

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，

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with poststroke depression; No intervention
Patients without poststroke depression; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Composition of Intestinal Microbial Communities Calculated by OTU Analysis	The composition were measured in number based on OTU data	2 weeks
The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis	Community diversity measured in the Shannon index	2 weeks
The Poststroke Depression 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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods	5-HT measured in mmol/L	2 weeks

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Yurong Zhang, PhD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: February 24, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: depression; ischemic stroke; intestinal microbiota
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder
• Other Study ID Numbers: XJTU1AF-CRF-2018-024

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