Ischemic StrokeNCT05113043
Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults
An observational study of Ischemic Stroke and Hemorrhagic Stroke, run by Shanghai 6th People's Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Clinical diagnosis of acute ischemic or hemorrhagic stroke
- Admission within 12 hours
- Aged 18-45 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Shanghai 6th People's Hospital
Shanghai, 200233
Hao Chen, M.D., Ph.D.
- Recruiting
Shanghai 6th People's Hospital
Shanghai, 200233
Lixia Xue, M.D., Ph.D.
About this study
Official title: Research on Correlation Between Intestinal Microecology Imbalance and the Risk and Prognosis of Stroke in Young Adults
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.
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- ischemic stroke, hemorrhagic stroke, intestinal microecology, multi-omics analysis, prognosis
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke | Young patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study. | |
| Hemorrhagic stroke | Young patients who suffered from acute hemorrhagic stroke within 12 hours for the first time before entry into the study. | |
| Healthy Controls | Healthy young people |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chen, MD, PhD, Shanghai 6th People's Hospital
- Investigators
- Lixia Xue, M.D., Ph.D., Study director, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113043
- Sponsor's protocol ID
- 2021-KY-112 (K)
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Correlation Between Intestinal Microecology Imbalance and the Risk and Prognosis of Stroke in Young Adults
- ClinicalTrials.gov ID
- NCT05113043
- Acronym / sponsor ID
- 2021-KY-112 (K)
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- ischemic stroke, hemorrhagic stroke, intestinal microecology, multi-omics analysis, prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke | – | –Young patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study. |
| Hemorrhagic stroke | – | –Young patients who suffered from acute hemorrhagic stroke within 12 hours for the first time before entry into the study. |
| Healthy Controls | – | –Healthy young people |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of acute ischemic or hemorrhagic stroke
- Admission within 12 hours
- Aged 18-45 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale scores
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lixia Xue, M.D., Ph.D. study director
Shanghai 6th People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Hemorrhagic Stroke, run by Shanghai 6th People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Chen, M.D., Ph.D. (02164369181 ext. 8405, chenhao_316@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.