Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorShanghai 6th People's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of acute ischemic or hemorrhagic stroke
Admission within 12 hours
Aged 18-45 years
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsGroup A: Ischemic stroke
Group B: Hemorrhagic stroke
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
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.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov