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Gut Microbiota in Acute Stroke Patients

Gut Microbiota in Acute Stroke Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03934021
Enrollment
120
Registered
2019-05-01
Start date
2018-07-01
Completion date
2024-08-30
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Stroke, Ischemic stroke, microbiome, atherosclerotic

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.

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.

Interventions

None listed

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The composition of gut-microbiota contributing neurological outcome between groups31 Dec, 2020Gene 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

MeasureTime frameDescription
The composition of gut-mircobiota contributing radiological finding between groups31 Dec, 2020Gene 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.

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORYiu Ming Bonaventure IP, MRCP

Chinese University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026