Gut Microbiota in Acute Stroke Patients

This study is to find out the significance of gut-microbiota in acute stroke patients, including their neurological, radiological outcomes as well as their stroke mechanisms.

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Key information

Conditions

Stroke Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cerebral Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Ischemic Stroke Microbiome Nervous System Diseases Stroke, Acute Stroke, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese University of Hong Kong

Hong Kong

About this study

Patients who suffered from acute stroke and in hospitalization in Prince of Wales Hospital will be recruited in the study.

After the informed consent, their first bowel opening will be collected for storage. They will also receive assessment by the stroke team at 3 and 6 months to determine their outcomes (NIHSS and mRS). Clinically and radiologically parameters including their degree of disability, imaging findings will also be collected to determine whether there are any correlations with the stool microbiota composition against matched individuals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed as acute ischaemic stroke
Aged 18 or above Chinese
Radiological evidence of acute ischaemic stroke by Computed tomography (CT) or magnetic resonance imaging (MRI) brain.

Exclusion criteria

Patient with symptoms and signs suggestive of alternative diagnoses,
Evidence of intracerebral haemorrhage,
Absence of DWI evidence of acute ischaemic infarct,
Pregnancy,
Evidence of gastrointestinal infection/ inflammation/ obstruction
History of partial or total resection of small or large bowel, as well as gut re-anastomosis,
Use of antibiotics within 2 weeks prior to symptoms onset,
Gastrointestinal malignancy
Any hospitalization within 3 months before recruitment
Institutionalized patients

Treatment and study plan

Primary outcomes

The composition of gut-microbiota contributing neurological outcome between groups

Time frame: 31 Dec, 2020

Gene sequencing of the 16S rRNA on the stool samples are performed to identify the microbes down to genus level, as well as the microbrobiota diversity and relative abundance. And stroke etiology classified by TOAST Classification and disability indices (NIHSS & mRS at baseline, 3 month & 6 month) will be recorded.

Secondary outcomes

The composition of gut-mircobiota contributing radiological finding between groups

Time frame: 31 Dec, 2020

Gene sequencing of the 16S rRNA on the stool samples are performed to identify the microbes down to genus level, as well as the microbrobiota diversity and relative abundance. All patients who received a plain CT brain & MRI for the diagnosis of stroke will be reviewed. Infarct volume in DWI, MR angiography abnormalities, presence of microbleed and/or haemorrhagic transformation will be documented.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: May 1, 2019
Registry last updated: Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed