Acute Ischemic StrokeNCT05414227
The Association of Gut Microbes and Their Metabolites With Post-stroke Depression
An observational study of Acute Ischemic Stroke, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
In this study, the clinical data of patients with AIS were collected, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma，to explore the influence of gut microbiota and its metabolites… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to 31 May 2023
- Phase
- Observational
- 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
Study population: Patients with ischemic stroke within 7 days of onset
Who may be able to join
- Patients who suffered from acute ischemic stroke
- Within 7 days of the onset
- Signing the informed consent, willing and able to attend all study visits
Who cannot join
- Severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate
- Previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics
- Gastrointestinal disease, and pregnant or lactating women
- Serious systemic diseases including malignant tumors
- Any antibiotics, probiotics or prebiotic treatment within 1 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Chen Renguo, Master
About this study
Official title: Research on the Association of Gut Microbes and Their Metabolites With Post-stroke Depression
In this study, the clinical data of patients with AIS were collected, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma，to explore the influence of gut microbiota and its metabolites on stroke prognosis.
Read the detailed description
In recent years, more and more studies have been conducted on the gut-brain axis, and gut microbes can affect the brain by regulating immune responses, metabolites, and neurotransmitters. The composition of gut microbiota may affect stroke prognosis, including focal neurological deficits, cognitive impairment, anxiety and depression, and fatigue. In this study, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma. The clinical data of patients were collected, including age, gender, and medical history, NIHSS, mRS, MMSE, Patient Health Questionnaire-9（PHQ9）, Social Support Rating Scale（SSRS）, laboratory and radiology results. The neurological recovery of the patients was assessed after 3 and 6 months, and the presence or absence of post-stroke depression（PSD） and post-stroke fatigue（PSF） was assessed by the Hamilton Depression Scale, the Fatigue Severity Scale（FSS） and the Multidimensional Fatigue Scale（MFS）. To evaluate the relationship between gut microbiota and its metabolites and stroke prognosis.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Gut flora, Acute Ischemic Stroke, Prognosis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSD | Depressed as assessed by the Hamilton Depression Scale 3 months after stroke | |
| Non PSD | Nondepressed as assessed by the Hamilton Depression Scale 3 months after stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24）
Measured: 3 months
The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24）
Measured: 6 months
The PSF Assessed by Fatigue Severity Scale（FSS）
Fatigue（≥36）
Measured: 3 months
The PSF Assessed by Fatigue Severity Scale（FSS）
Fatigue（FSS Score ≥36）
Measured: 6 months
Functional Independence Assessed by Modified Rankin Scale (mRS）score
MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6)
Measured: 3 months
Functional Independence Assessed by Modified Rankin Scale (mRS）score
MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6)
Measured: 6 months
Secondary outcomes (3)
Gut microbial composition and diversity
Results of fecal bacteria by 16s RNA sequencing
Measured: First stool after admission
Serum metabolites of gut microbiota
Serum metabolites of gut microbiota from stool, detected by liquid chromatography-mass spectrometry (LC-MS) combined technique
Measured: 7 days within stroke onset
Serum inflammatory cytokines
Inflammatory cytokines in blood，detected by flow cytometry
Measured: 7 days within stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start6 Jun 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Renguo, Master, Study chair, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414227
- Sponsor's protocol ID
- XYFY2022-KL204
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Association of Gut Microbes and Their Metabolites With Post-stroke Depression
- ClinicalTrials.gov ID
- NCT05414227
- Acronym / sponsor ID
- XYFY2022-KL204
- Conditions
- Acute Ischemic Stroke
- Keywords
- Gut flora, Acute Ischemic Stroke, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 10 Jun 2022 (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.
In this study, the clinical data of patients with AIS were collected, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma，to explore the influence of gut microbiota and its metabolites on stroke prognosis.
Detailed description
In recent years, more and more studies have been conducted on the gut-brain axis, and gut microbes can affect the brain by regulating immune responses, metabolites, and neurotransmitters. The composition of gut microbiota may affect stroke prognosis, including focal neurological deficits, cognitive impairment, anxiety and depression, and fatigue. In this study, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma. The clinical data of patients were collected, including age, gender, and medical history, NIHSS, mRS, MMSE, Patient Health Questionnaire-9（PHQ9）, Social Support Rating Scale（SSRS）, laboratory and radiology results. The neurological recovery of the patients was assessed after 3 and 6 months, and the presence or absence of post-stroke depression（PSD） and post-stroke fatigue（PSF） was assessed by the Hamilton Depression Scale, the Fatigue Severity Scale（FSS） and the Multidimensional Fatigue Scale（MFS）. To evaluate the relationship between gut microbiota and its metabolites and stroke prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSD | – | –Depressed as assessed by the Hamilton Depression Scale 3 months after stroke |
| Non PSD | – | –Nondepressed as assessed by the Hamilton Depression Scale 3 months after stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke within 7 days of onset
Key inclusion criteria (3 listed)
- Patients who suffered from acute ischemic stroke
- Within 7 days of the onset
- Signing the informed consent, willing and able to attend all study visits
Key exclusion criteria (5 listed)
- Severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate
- Previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics
- Gastrointestinal disease, and pregnant or lactating women
- Serious systemic diseases including malignant tumors
- Any antibiotics, probiotics or prebiotic treatment within 1 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
Time frame: 3 months
Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24）
The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
Time frame: 6 months
Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24）
The PSF Assessed by Fatigue Severity Scale（FSS）
Time frame: 3 months
Fatigue（≥36）
The PSF Assessed by Fatigue Severity Scale（FSS）
Time frame: 6 months
Fatigue（FSS Score ≥36）
Functional Independence Assessed by Modified Rankin Scale (mRS）score
Time frame: 3 months
MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6)
Functional Independence Assessed by Modified Rankin Scale (mRS）score
Time frame: 6 months
MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6)
3 secondary outcomes
Gut microbial composition and diversity
Time frame: First stool after admission
Serum metabolites of gut microbiota
Time frame: 7 days within stroke onset
Serum inflammatory cytokines
Time frame: 7 days within stroke onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Chen Renguo, Master study chair
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by The Affiliated Hospital of Xuzhou Medical University 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 3 inclusion and 5 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 10 Jun 2022. 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 Zhang Wei, Master (15162113531, neurodoc0708@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2022.