Gut Microbiota in Acute Stroke Patients

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Stroke; Microbiome; Stroke, Acute; Atherosclerosis Cerebral; Stroke, Ischemic

Study type: Observational

Funder types: Other

Identifiers

NCT03934021

crec 2016.545

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

200 participants in 2 patient groups

Acute stroke patient group

Description:

Consecutive patients diagnosed with acute ischaemic stroke during hospitalization in Prince of Wales Hospital will be recruited. After an informed consent, stool will be collected from enrolled patients in their first bowel opening after hospitalization and stored in a freezer (-80 degree Celsius) within 24 hours for analysis. If a subject develops constipation, stool sampling will be facilitated by stool softener or laxatives. Stools samples will be stored at -80 degrees Celsius within 24 hours once it is collected. Subjects will be followed up at 3 and 6 months after trial entry. NIHSS and mRS will be performed at each visit. Stool sample collection will be repeated in 6 months visit only.

Control group

Description:

Age and disease matched subjects will be invited to join the study as the control. Stool will also be collected for the comparison of gut microbiota with acute stroke patients to look for evidence of gut dysbiosis in acute stroke. We shall match the control cohort with the stroke cohort in terms of age, gender, smoking status, medical co-morbidities including hypertension, hyperlipidaemia, diabetes, (atrial fibrillation), use of medications in particular metformin, proton pump inhibitors and aspirin.