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出境医 / 临床实验 / Gut Microbiota in Acute Stroke Patients

Gut Microbiota in Acute Stroke Patients

Study Description
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.

Condition or disease
Stroke Stroke, Acute Stroke, Ischemic 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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gut Microbiota in Acute Stroke Patients
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022
Arms 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.
Outcome Measures
Primary Outcome Measures :
  1. The composition of gut-microbiota contributing neurological outcome between groups [ Time Frame: 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.


Secondary Outcome Measures :
  1. The composition of gut-mircobiota contributing radiological finding between groups [ Time Frame: 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. 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.


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations

Contacts
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Contact: Yiu Ming Bonaventure IP, MRCP 852-35053856 iym984@ha.org.hk

Locations
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Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Yiu Ming Bonaventure Ip, MRCP    852-35053856    iym984@ha.org.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Yiu Ming Bonaventure IP, MRCP Chinese University of Hong Kong
Tracking Information
First Submitted Date April 25, 2019
First Posted Date May 1, 2019
Last Update Posted Date October 28, 2020
Actual Study Start Date July 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2019) 		The composition of gut-microbiota contributing neurological outcome between groups [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 30, 2019) 		The composition of gut-mircobiota contributing radiological finding between groups [ Time Frame: 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. 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gut Microbiota in Acute Stroke Patients
Official Title Gut Microbiota in Acute Stroke Patients
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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
Condition
  • Stroke
  • Stroke, Acute
  • Stroke, Ischemic
  • Microbiome
  • Atherosclerosis Cerebral
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 30, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yiu Ming Bonaventure IP, MRCP 852-35053856 iym984@ha.org.hk
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934021
Other Study ID Numbers crec 2016.545
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dr. IP Yiu Ming Bonaventure, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators Not Provided
Investigators
Principal Investigator: Yiu Ming Bonaventure IP, MRCP Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date October 2020

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