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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute; 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yiu Ming Bonaventure Ip, MRCP; Phone Number: 852-35053856; Email: iym984@ha.org.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Yiu Ming Bonaventure Ip, MRCP; Phone Number: 852-35053856; Email: iym984@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients diagnosed with acute ischaemic stroke during hospitalization in PWH will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria. Control group will be recruited from medical out patient clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composition of gut-microbiota contributing neurological outcome between groups	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.	31 Dec, 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composition of gut-mircobiota contributing radiological finding between groups	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.	31 Dec, 2020

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Yiu Ming Bonaventure IP, MRCP, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; microbiome; atherosclerotic; Ischemic stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stroke; Ischemic Stroke; Atherosclerosis
• Other Study ID Numbers: crec 2016.545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No