Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults

January 19, 2024 updated by: Hao Chen, MD, PhD, Shanghai 6th People's Hospital

Research on Correlation Between Intestinal Microecology Imbalance and the Risk and Prognosis of Stroke in Young Adults

The relationship between the intestinal microecology and stroke has become a research hotspot in neurology field today. Maintaining the balance of the intestinal microbiota are expected to bring new breakthroughs for prevention and treatment of stroke. In recent years, stroke in young adults has an increasing incidence and a considerable socioeconomic impact because of high disability rate and health-care costs. So there is an urgent need to explore the role and mechanism of intestinal microecology imbalance in stroke, especially in the development and prognosis of stroke in young people. This study aims to use multi-omics technologies, including microbial diversity, metagenomics and metabonomics, to reveal the characteristics of intestinal flora in young stroke patients, identify biomarkers for predicting outcome after stroke and early detection of young people at high risk of stroke, and to further explore the role of gut-brain axis in the pathogenesis of stroke.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200233
        • Recruiting
        • Shanghai 6th People's Hospital
        • Contact:
          • Lixia Xue, M.D., Ph.D.
      • Shanghai, China, 200233
        • Not yet recruiting
        • Shanghai 6th People's Hospital
        • Contact:
          • Hao Chen, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Young patients (18-45 years old) with ischemic or hemorrhagic stroke, who are admitted within 12 hours post-stroke are included. To avoid interfering factors, patients with existing prior neurological disease or known tumors, inflammatory bowel disease and other digestive system diseases, patients with serious life-threatening diseases or condition, patients under antibiotics, probiotics or prebiotic treatment within 3 months before stroke, and patients who deteriorate and die before collecting faecal samples are excluded. Clinical data are documented, including age, gender, types of stroke as evidenced by imaging examination and laboratory examination, etc.

Description

Inclusion Criteria:

  • Clinical diagnosis of acute ischemic or hemorrhagic stroke
  • Admission within 12 hours
  • Aged 18-45 years

Exclusion Criteria:

  • History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
  • Combined with tumors, inflammatory bowel disease and other digestive system diseases
  • Combined with serious life-threatening diseases or condition
  • Any antibiotics, probiotics or prebiotic treatment within 3 months
  • Deteriorate and die before collecting faecal samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ischemic stroke
Young patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study.
Hemorrhagic stroke
Young patients who suffered from acute hemorrhagic stroke within 12 hours for the first time before entry into the study.
Healthy Controls
Healthy young people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale scores
Time Frame: 3 months
0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Investigators

  • Study Director: Lixia Xue, M.D., Ph.D., Shanghai 6th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-KY-112 (K)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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