Gut Microbiota in Acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The composition of gut-microbiota contributing neurological outcome between groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient with symptoms and signs suggestive of alternative diagnoses,
- •Evidence of intracerebral haemorrhage,
- •Absence of DWI evidence of acute ischaemic infarct,
- •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
研究组 & 干预措施
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.
结局指标
主要结局
The composition of gut-microbiota contributing neurological outcome between groups
时间窗: 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.
次要结局
- The composition of gut-mircobiota contributing radiological finding between groups(31 Dec, 2020)
研究者
Dr. IP Yiu Ming Bonaventure
Clinical Tutor
Chinese University of Hong Kong