Gut Microbiota in Acute Stroke Patients

Stroke Clinical Trial

Official title:

Gut Microbiota in Acute Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03934021
• Other study ID #: crec 2016.545
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Yiu Ming Bonaventure IP, MRCP
• Phone: 852-35053856
• Email: iym984[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis Cerebral
• Ischemic Stroke
• Microbiome
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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