Gut microbiota changes after an ischemic stroke.

Investigation Into the Gut Microbiota-Immune-Inflammatory Interaction Network and Its Mechanisms in Patients With Ischemic Stroke

This study will test whether and how gut bacteria change after a first acute ischemic stroke and whether those changes relate to recovery in adults admitted within 48 hours of symptom onset.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Affiliated Hospital of Nantong University (Academic / other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT07247838 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort with control elements that will collect stool samples shortly after hospital admission and during follow-up to profile gut microbiota. Participants are first-time acute ischemic stroke patients admitted within 48 hours, with NIHSS ≥4, and those who recently used antibiotics or probiotics are excluded. The study will compare microbiota composition over time and correlate microbial signatures with clinical outcomes such as neurological status and functional recovery at three months. The work is conducted at the Affiliated Hospital of Nantong University with collaboration from Zhejiang University.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with a first acute ischemic stroke, NIHSS score ≥4, who can provide an initial stool sample within 48 hours of symptom onset, can give informed consent, and have not used antibiotics or probiotics in the prior month.

Not a fit: Patients who recently used antibiotics or probiotics, have active infections, major organ dysfunction, prior major gastrointestinal disease, cannot provide stool samples, or cannot consent are unlikely to benefit from this observational protocol.

Why it matters

Potential benefit: If successful, the study could identify microbial patterns linked to better or worse recovery and point toward microbiome-based prevention or therapy strategies.

How similar studies have performed: Previous observational studies have reported links between gut microbiota composition and stroke outcomes, but prospective cohort data are limited and interventional proof remains sparse.

Eligibility criteria

Inclusion Criteria:

(1) First-time acute ischemic stroke patients must have completed initial sample collection within 48 hours of symptom onset and hospital admission; (2) Participants must be aged 18 or older, with no gender restrictions; (3) Stroke patients must have a National Institutes of Health Stroke Scale (NIHSS) score of 4 or higher; (4) Participants must fully understand the study protocol and provide informed consent.

Exclusion Criteria:

(1) Patients who have taken antibiotics or probiotics within one month prior to hospitalization or during follow-up; (2) Patients with infectious diseases such as pneumonia or urinary tract infections; (3) Patients who cannot obtain stool samples within three days after hospitalization or during three-month follow-up; (4) Patients with severe dysfunction of major organs including heart, lungs, liver, or kidneys; (5) Patients who have not provided or are unable to provide informed consent; (6) Patients with a history of major gastrointestinal diseases; (7) Patients with other severe neurological disorders; (8) Patients deemed unsuitable by investigators to participate in this clinical study.

Where this trial is running

Nantong, Jiangsu

• Affiliated Hospital of Affiliated Hospital — Nantong, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Xiao MB Director of scientific research Department, Doctor — Affiliated Hospital of Nantong University
• Study coordinator: Gao YT Director of the Department of Anesthesiology, Master

Conditions Ischemic Stroke; Gut Microbiota