MedDataX Logo

Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study

NCT ID: NCT04978701

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was designed as a prospective, observational, multicenter cohort study. 2000 patients with AIS will be enrolled continuously through multiple centers. Oral swabs, feces (the day after admission, 1 month, 3 months after the onset of disease) and blood samples (the day after admission, 3 months after the onset of disease) will be collected. After the onset of the disease (1 month, 3 months, 6 months and 12 months), outpatient/telephone follow-up will be conducted to evaluate the neurological function scores of the patients, and the recurrence of stroke and other cardio-cerebrovascular events will be recorded.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

acute ischemic stroke, microbiome, prognosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Meet the AIS diagnostic criteria;
* Age 18-80;
* Within 7 days of the onset;
* Signing the informed consent, providing relevant medical history and biological specimens.

Exclusion Criteria

* mRS \> score 2 before onset;
* Serious systemic diseases including malignant tumors;
* Hematological diseases and autoimmune diseases;
* ALT or AST \> 2 times the upper limit of normal value or severe liver disease;
* Serum creatinine \> 1.5 times the upper normal limit or severe nephropathy;
* History of alcoholism, drug abuse, and chemical poisoning (e.g. pesticide poisoning);
* History of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital;
* Antibiotic use within 1 month before admission;
* Fece cannot be obtained within 4 days after admission.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Guangdong Yanling Hospital

UNKNOWN

Sponsor Role collaborator

Shenzhen University General Hospital

OTHER

Sponsor Role collaborator

The First Hospital Of Qiqihar

UNKNOWN

Sponsor Role collaborator

Huzhou Central Hospital

OTHER

Sponsor Role collaborator

Zhejiang Greentown Cardiovascular Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Leshan, Sichuan Province

UNKNOWN

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

yinjia

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yin Jia, Master

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, NanFang Hospital, Southern Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Neurology, NanFang Hospital, Southern Medical University

Guanzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yin Jia, Master

Role: CONTACT

Phone: +86 13802964883

Email: [email protected]

Zhang Mingsi, Master

Role: CONTACT

Phone: +86 13827003570

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yin Jia, master's degree

Role: primary

Zhang Mingsi

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NFEC-2021-220

Identifier Type: -

Identifier Source: org_study_id