Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults

Recruiting

• Conditions: Ischemic Stroke; Hemorrhagic Stroke

• Registration Number: NCT05113043
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-09
• Study Start: 2022-02-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale scores	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.

Trial Locations

Locations (1)

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, China