Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113043
• Other study ID #: 2021-KY-112 (K)
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Shanghai 6th People's Hospital
• Contact: Hao Chen, M.D., Ph.D.
• Phone: 02164369181
• Email: chenhao_316[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Shanghai 6th People's Hospital	Shanghai
China	Shanghai 6th People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale scores	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