Prospective Cohort Control Study on Changes in Gut Microbiota in Ischemic Stroke

NCT07247838 | Recruiting DMC

• 1 other identifier: 2025-k257-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Stroke stands as one of the leading causes of death and long-term disability worldwide, imposing a substantial socioeconomic burden. Annual new stroke cases are estimated between 9.5 million and 10.6 million. Stroke survivors commonly face challenges of poor long-term functional outcomes and compromised immunity, which not only drive quality-of-life deterioration but also fuel the persistent escalation of socioeconomic burdens. However, current clinical treatments for stroke prognosis improvement remain limited. In recent years, with the emergence of the "microbiota-gut-brain axis" concept and advancing research, the role of gut microbiota in stroke onset, progression, and prognosis regulation has garnered increasing attention.
2. 2.Purpose of this study To investigate the mechanisms by which gut microbiota and their metabolites improve the physiological and neurological functions of stroke patients, and to provide new therapeutic approaches for improving the prognosis of stroke patients.
3. 3.Research Design 3.1 Research Methodology This is a single-center, non-interventional, cohort-controlled clinical study that randomly enrolled 100 stroke patients and 100 healthy individuals. The participants were divided into a stroke group (case group, CS group) and a healthy control group (CON group), with 100 cases in each group. The primary objectives were to investigate the gut microbiota composition, intestinal barrier function, and inflammatory cytokine levels in stroke patients versus healthy controls, while exploring the mechanisms of beneficial gut microbiota in stroke recovery. This research may provide new therapeutic approaches to address current treatment limitations.

Conditions

Ischemic Stroke

Keywords

Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• Gut microbiota composition

  Fecal samples were processed using the QIAmp DNA Stool Fast Kit (QIAGEN, Hilden, Germany) for bacterial genome DNA extraction. The genomic library was constructed and sequenced on the MiSeq 300×2 V3 Kit (Illumina, USA) platform to comprehensively analyze the intestinal microbiota structure and composition. Bioinformatics analysis of the sequencing results included OTU generation and Rank-abundance analysis, sampling adequacy assessment, abundance and diversity analysis, microbial community differences, principal component analysis (PCA), hypothesis testing, and phylogenetic tree construction.

  Within 48 hours of admission

Secondary Outcomes (1)

• Multiple cytokines

  Within 48 hours of admission

Other Outcomes (1)

• Patient info

  Before enrollment

Study Arms (2)

Stroke group

1. For patients with acute ischemic stroke for the first time, the time from symptom onset to hospitalization and completion of the first sample collection was within 48 hours; 2. Over 18 years old, male or female; 3. Patients with ischemic stroke who scored ≥4 on the National Institutes of Health Stroke Scale (NIHSS);

Healthy Volunteer Group

Healthy volunteers with no history of ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic stroke

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Zhejiang University: collaborator

Study Sites (1)

Affiliated Hospital of Affiliated Hospital

Nantong, Jiangsu, 226400, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiao MB Director of scientific research Department, Doctor

  The Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao YT Director of the Department of Anesthesiology, Master

CONTACT

13962988003; gyt19700114@sina.com

Liu YF project implementation PI, Master

CONTACT

13506289927; winters_cool@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Anesthesiology Department

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)