Gut Microbiota in Acute Stroke Patients

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT03934021

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke, Acute Stroke, Ischemic Microbiome Atherosclerosis Cerebral

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Gut Microbiota in Acute Stroke Patients

Actual Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Acute stroke patient group 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 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.

Arm

Intervention/Treatment

Acute stroke patient group

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

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.

Outcome Measures

Primary Outcome Measures

The composition of gut-microbiota contributing neurological outcome between groups [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 Outcome Measures

The composition of gut-mircobiota contributing radiological finding between groups [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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