Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults

NCT ID: NCT05113043

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke Hemorrhagic Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ischemic stroke

Young patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study.

No interventions assigned to this group

Hemorrhagic stroke

Young patients who suffered from acute hemorrhagic stroke within 12 hours for the first time before entry into the study.

No interventions assigned to this group

Healthy Controls

Healthy young people

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hao Chen, MD, PhD

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lixia Xue, M.D., Ph.D.

Role: STUDY_DIRECTOR

Shanghai 6th People's Hospital

Locations

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Shanghai 6th People's Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Shanghai 6th People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Chen, M.D., Ph.D.

Role: CONTACT

02164369181 ext. 8405

Facility Contacts

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Hao Chen, M.D., Ph.D.

Role: primary

Lixia Xue, M.D., Ph.D.

Role: primary

Other Identifiers

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2021-KY-112 (K)

Identifier Type: -

Identifier Source: org_study_id

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