Gut Microbiota in Acute Stroke Patients

NCT03934021 | Completed

• 1 other identifier: crec 2016.545
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stroke; Ischemic stroke; microbiome; atherosclerotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The composition of gut-mircobiota contributing radiological finding between groups

  31 Dec, 2020

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stools samples will be stored at -80 degrees Celsius within 24 hours after collection. 16S rRNA gene amplicons will be obtained through DNA extraction, PCR amplification and purification using available kits. After pyrosequencing, sequences will be analysed using mother pipeline and grouped into operational taxonomic units and classified using GreenGenes. OTU based microbial diversity was estimated by calculating the nonparametric Shannon diversity index. Alpha diversity and abundance profiles will be used for downstream statistical and modeling analysis.

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Yiu Ming Bonaventure IP, MRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Tutor

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 1, 2019
• Study Start: July 1, 2018
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

HK (1)