StrokeIFEPSDAISNCT03863951
Poststroke Depression of Clinical Trial Registration
An observational study of Stroke and Depression, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Depression
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2019to 28 Feb 2021
- How long will I take part?
- 3 Months
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: acute ischemic stroke patients
Who may be able to join
- diagnosed with the first ever acute ischemic stroke occurring within 2 weeks and were confirmed by CT or MRI,
- has no history of depression or use of antidepressants or antipsychotics,
- were competent to consent to take part in this research.
Who cannot join
- significant acute or severe illness such as infection,heart failure and tumor,
- previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics,
- antibiotics in the last two weeks,
- severe aphasia or dysarthria,irritable bowel syndrome,asthma,and pregnant or lactating women,
- a previous history of neurological illness including AD and PD，
- Inflammatory bowel disease，
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yurong Zhang
Xi'an, Shaanxi
Yurong Zhang, zhangyurong72@mail.xjtu.edu.cn
About this study
Official title: The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke
The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.
Read the detailed description
In this study, patients with first ever acute ischemic stroke were studied. According to the psychological assessment, patients were divided into two groups according to whether or not there was a PSD at the earlier stage of stroke. Clinical biological data and blood and feces samples were collected. Firstly, 16srDNA sequencing was used to study the difference in the composition and diversity of intestinal microbial communities in the two groups of patients. Then the two groups selected individual representative samples and conducted macro genome sequencing. At the same time, by analyzing the correlation between the intestinal flora and the clinical risk factors and neurotransmitters in early PSD patients, the key functional bacteria related to PSD were identified.
- Conditions
- Stroke, Depression
- Keywords
- ischemic stroke, depression, intestinal microbiota
- Medical subject headings
- Stroke, Depression, 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 |
|---|---|---|
| Patients with poststroke depression | No intervention | |
| Patients without poststroke depression | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Composition of Intestinal Microbial Communities Calculated by OTU Analysis
The composition were measured in number based on OTU data
Measured: 2 weeks
The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis
Community diversity measured in the Shannon index
Measured: 2 weeks
The Poststroke Depression 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
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
Secondary outcomes (1)
The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods
5-HT measured in mmol/L
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start20 Jan 2019
- Primary completion31 May 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yurong Zhang, PhD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863951
- Sponsor's protocol ID
- XJTU1AF-CRF-2018-024
- Acronym
- IFEPSDAIS
- Status last verified
- Jan 2019
- First submitted
- 24 Feb 2019
- Last updated
- 5 Mar 2019
- 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 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03863951
- Acronym / sponsor ID
- IFEPSDAIS / XJTU1AF-CRF-2018-024
- Conditions
- Stroke, Depression
- Keywords
- ischemic stroke, depression, intestinal microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 5 Mar 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 investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.
Detailed description
In this study, patients with first ever acute ischemic stroke were studied. According to the psychological assessment, patients were divided into two groups according to whether or not there was a PSD at the earlier stage of stroke. Clinical biological data and blood and feces samples were collected. Firstly, 16srDNA sequencing was used to study the difference in the composition and diversity of intestinal microbial communities in the two groups of patients. Then the two groups selected individual representative samples and conducted macro genome sequencing. At the same time, by analyzing the correlation between the intestinal flora and the clinical risk factors and neurotransmitters in early PSD patients, the key functional bacteria related to PSD were identified.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with poststroke depression | – | –No intervention |
| Patients without poststroke depression | – | –No intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- acute ischemic stroke patients
Key inclusion criteria (3 listed)
- diagnosed with the first ever acute ischemic stroke occurring within 2 weeks and were confirmed by CT or MRI,
- has no history of depression or use of antidepressants or antipsychotics,
- were competent to consent to take part in this research.
Key exclusion criteria (6 listed)
- significant acute or severe illness such as infection,heart failure and tumor,
- previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics,
- antibiotics in the last two weeks,
- severe aphasia or dysarthria,irritable bowel syndrome,asthma,and pregnant or lactating women,
- a previous history of neurological illness including AD and PD，
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 Composition of Intestinal Microbial Communities Calculated by OTU Analysis
Time frame: 2 weeks
The composition were measured in number based on OTU data
The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis
Time frame: 2 weeks
Community diversity measured in the Shannon index
The Poststroke Depression 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）
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).
1 secondary outcome
The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- 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.
Yurong Zhang, PhD study chair
First Affiliated Hospital Xi'an Jiaotong 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 Stroke and Depression, run by First Affiliated Hospital Xi'an Jiaotong 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 6 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 5 Mar 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 Yurong Zhang, PhD (0086-029-85323443, zhangyurong72@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Composition of Intestinal Microbial Communities Calculated by OTU Analysis (time frame: 2 weeks). The study lists 4 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 5 Mar 2019.