NCT05414227

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 8, 2022

Last Update Submit

June 8, 2022

Conditions

Acute Ischemic Stroke

Keywords

Gut floraAcute Ischemic StrokePrognosis

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • Gut microbial composition and diversity

    First stool after admission

  • Serum metabolites of gut microbiota

    7 days within stroke onset

  • Serum inflammatory cytokines

    7 days within stroke onset

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ischemic stroke within 7 days of onset

You may qualify if:

  • Patients who suffered from acute ischemic stroke
  • Within 7 days of the onset
  • Signing the informed consent, willing and able to attend all study visits

You may not qualify if:

  • Severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate
  • Previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics
  • Gastrointestinal disease, and pregnant or lactating women
  • Serious systemic diseases including malignant tumors
  • Any antibiotics, probiotics or prebiotic treatment within 1 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Faecal samples

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chen Renguo, Master

    The Affiliated Hospital of Xuzhou Medical University

    STUDY CHAIR

Central Study Contacts

Zhang Wei, Master

CONTACT

15162113531neurodoc0708@126.com

Hua Fang, PhD

CONTACT

15252144898huafang@xzmc.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 10, 2022

Study Start

June 6, 2022

Primary Completion

February 28, 2023

Study Completion

May 31, 2023

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)