Clinical trial NCT05113043: Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults
Official title: Research on Correlation Between Intestinal Microecology Imbalance and the Risk and Prognosis of Stroke in Young Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Keywords: ischemic stroke
hemorrhagic stroke
intestinal microecology
multi-omics analysis
prognosis
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale scores
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Lixia Xue, M.D., Ph.D.
role: STUDY_DIRECTOR
References: