Gastrointestinal MicrobiomeNCT03812445
Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
A study testing Probiotics in people with Gastrointestinal Microbiome, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Microbiome
- What is being tested?
- Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria1.
- the time from paroxysm to admission ≤2weeks.
Who cannot join
- Imaging diagnoses hemorrhagic stroke Severe depression Severe disturbance of hearing vision and reading Illiteracy Have recognitive disorder before stroke (recorded in medical records) Treated with antibiotics probiotics or prebiotics in1month before admission
Trial locations and contacts
1 site in 1 country.
Hao Li, MD contact
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, 20072
Yongqiang Liu, postgraduate, 18321785703, 3101702346@qq.com
Huanlong Qin, PhD
About this study
Official title: The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.
Read the detailed description
This study aims to detect the impact of probiotics administration during the process of ischemic stroke treatment and recovery phase. The day of admission and 3months after stroke data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the stroke patients.
- Conditions
- Gastrointestinal Microbiome
- Being tested
- Probiotics
- Keywords
- Probiotics, Gut microbiota, ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus,Bifidobacterium lactobacillus,Lactobacillus paracasei,Lactobacillus rhamnosus and Lactobacillus fermentium with does of 8*10^9 Colony-Forming Units(CFU) *2/d for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | the patients in this arm will not receive probiotics. |
| Experimental | Experimental | the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months. Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from admission on gut microbiome at 3months by genome sequencing
change of the gut microbiome will be calculated at 3months in comparison with admission.
Measured: 3months
Secondary outcomes (2)
change from admission on cognitive function at 3months by Montreal Cognitive Assessment.
change from admission on cognitive function at 3months by Montreal Cognitive Assessment (MoCA). MoCA's score is from 0 to 30.the score is lower,the cognitive disorder is worse.
Measured: 3months
change from admission on emotion at 3months by Hamilton Depression Scale.
change from admission on emotion at 3months by Hamilton Depression Scale（HAMD） .When HAMD's score is beyond 17,the patient is considered to have minor depression.When HAMD's score is beyond 20,the patient is considered to have medium depression. When HAMD's score is beyond 30,the patient is considered to have severe depression.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jun 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
- Investigators
- Huanlong Qin, Study chair, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812445
- Sponsor's protocol ID
- cognitionstroke
- Status last verified
- Feb 2019
- First submitted
- 3 Jan 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clottes P, Benech N, Dumot C, Jarraud S, Vidal H, Mechtouff L. Gut microbiota and stroke: New avenues to improve prevention and outcome. Eur J Neurol. 2023 Nov;30(11):3595-3604. doi: 10.1111/ene.15770. Epub 2023 Apr 6.
PubMed 36897813
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03812445
- Acronym / sponsor ID
- cognitionstroke
- Conditions
- Gastrointestinal Microbiome
- Keywords
- Probiotics, Gut microbiota, ischemic stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.
Detailed description
This study aims to detect the impact of probiotics administration during the process of ischemic stroke treatment and recovery phase. The day of admission and 3months after stroke data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –the patients in this arm will not receive probiotics. |
| Experimental | Experimental | Dietary Supplement: Probioticsthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria1.
- the time from paroxysm to admission ≤2weeks.
Key exclusion criteria (1 listed)
- Imaging diagnoses hemorrhagic stroke Severe depression Severe disturbance of hearing vision and reading Illiteracy Have recognitive disorder before stroke (recorded in medical records) Treated with antibiotics probiotics or prebiotics in1month before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probioticsthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus,Bifidobacterium lactobacillus,Lactobacillus paracasei,Lactobacillus rhamnosus and Lactobacillus fermentium with does of 8*10^9 Colony-Forming Units(CFU) *2/d for 3 months. | Dietary supplement | Experimental |
Primary outcome
change from admission on gut microbiome at 3months by genome sequencing
Time frame: 3months
change of the gut microbiome will be calculated at 3months in comparison with admission.
2 secondary outcomes
change from admission on cognitive function at 3months by Montreal Cognitive Assessment.
Time frame: 3months
change from admission on emotion at 3months by Hamilton Depression Scale.
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Derived from this study: PubMed 36897813Clottes P, Benech N, Dumot C, Jarraud S, Vidal H, Mechtouff L. Gut microbiota and stroke: New avenues to improve prevention and outcome. Eur J Neurol. 2023 Nov;30(11):3595-3604. doi: 10.1111/ene.15770. Epub 2023 Apr 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Li, MD contact
Huanlong Qin study chair
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Gastrointestinal Microbiome, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongqiang Liu, postgraduate (18321785703, 3101702346@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from admission on gut microbiome at 3months by genome sequencing (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03812445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.