Lupus Erythematosus, SystemicNCT05636670
Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease
An observational study of Lupus Erythematosus, Systemic and Gastrointestinal Microbiome, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Based on clinical manifestations, laboratory data and intestinal microflora detection, the cognitive function characteristics of patients with systemic lupus erythematosus and cerebrovascular disease and its relationship with intestinal microflora were analyzed to explore the possible pathogenesis of lupus… Read more about this study
- Who is it for?
- Ages 14 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Systemic, Gastrointestinal Microbiome
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Sep 2024
- 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 14 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Diagnostic criteria: Patients diagnosed with systemic lupus erythematosus are classified as SLE by the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019. Brain imaging cerebrovascular changes were defined as: great vascular lesions including cerebral infarction, cerebral hemorrhage, venous sinus thrombosis; Microvascular lesions include leukodystrophy, cerebral atrophy, perivascular space enlargement, lacunar infarction, cerebral microhemorrhage focus, and recent subcortical infarction.
Who may be able to join
- Retrospective study
- Patients enrolled from September 2018 to September 2021 applied for exemption from informed consent, and patients enrolled from September 2021 to September 2022 signed informed consent voluntarily.
- Male or female patients aged 14-55 years;
- Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019.
- Cranial imaging examination was performed, and the results of cranial imaging examination were consistent with cerebrovascular disease changes.
- Prospective Research:
Show all 21Show fewer
- SLE group:
- The researcher signed the informed consent voluntarily;
- Male or female patients aged 14-55 years;
- Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019.
- Patients who need to undergo head imaging examination according to the judgment of treating doctors, and the results of head imaging examination are not consistent with changes in cerebrovascular disease.
- No antibiotics have been taken in the past 2 weeks; SLE cerebrovascular disease group
- The researcher signed the informed consent voluntarily;
- Male or female patients aged 14-55 years
- Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019.
- no antibiotics have been taken in the past 2 weeks;
- Healthy control group:
- Male or female patient volunteers aged 14-55 from the Health Examination Center of Nanfang Hospital,
- Voluntary signing of informed consent;
- No systemic disease;
- According to the judgment of the researchers, healthy volunteers matching SLE group in age, gender and education level were selected as the control group;
Who cannot join
- Patients with other autoimmune diseases;
- Brain imaging suggested central nervous system infection, space occupation and other manifestations.
- Patients with malignant tumors and active tuberculosis;
- Pregnancy, lactation or intended pregnancy, women of childbearing age do not use effective contraceptive measures (IUD, oral contraceptives and obstruction measures);
- History of cerebrovascular disease not associated with SLE as determined by the investigator
- The researcher judged that it is not suitable to participate in this researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qin Huang
Guangzhou, Guangdong
Qin Huang, 13632430850, qinzihq@foxmail.com
About this study
Official title: Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease: a Retrospective and Prospective Cohort Study
Based on clinical manifestations, laboratory data and intestinal microflora detection, the cognitive function characteristics of patients with systemic lupus erythematosus and cerebrovascular disease and its relationship with intestinal microflora were analyzed to explore the possible pathogenesis of lupus cerebrovascular disease.
Read the detailed description
This study was a retrospective and prospective cohort study. They were divided into three groups, namely SLE group, SLE cerebrovascular disease group and healthy control group. Each group included 60 patients [Anticipated].
- Retrospective study: The SLE patients admitted to Nanfang Hospital from 2018 to 2022 were retrieved. The patients enrolled from September 2018 to September 2021 applied for exemption from informed consent, and the patients enrolled from September 2021 to September 2022 voluntarily signed informed consent. Patients were selected according to inclusion and exclusion criteria, and clinical and laboratory data of all subjects were recorded.
- Prospective study: Obtain the consent of the subjects, sign the informed consent, and record the clinical and laboratory examination data of all the subjects. (1) Cognitive function assessment; (2) Fresh stool and serum were collected, and 16s rRNA technology was used for intestinal flora detection, and QIIME2 platform was used for flora analysis; Serum inflammatory factors were detected and metabolomic analysis was performed.
The clinical data of all enrolled patients were statistically analyzed.
- Medical subject headings
- Lupus Erythematosus, Systemic
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 |
|---|---|---|
| SLE group | 1. The researcher signed the informed consent voluntarily; 2. Male or female patients aged 14-55 years; 3. Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019. 4. Patients who need to undergo head imaging examination according to the judgment of treating doctors, and the results of head imaging examination are not consistent with changes in cerebrovascular disease. 5. no antibiotics have been taken in the past 2 weeks; | |
| NPSLE epilepsy group | 1. The researcher signed the informed consent voluntarily; 2. Male or female patients aged 14-55 years 3. Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019. 4. Patients who need MRI according to the judgment of the treating doctor, and reveal that the MRI suggests cerebrovascular disease; 5. no antibiotics have been taken in the past 2 weeks; | |
| Healthy control group | 1. Male or female patient volunteers aged 14-55 from the Health Examination Center of Nanfang Hospital, 2. Voluntary signing of informed consent; 3. no systemic disease; 4. According to the judgment of the researchers, healthy volunteers matching SLE group in age, gender and education level were selected as the control group; |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess changes in cognitive function by Mini-mental State Examination
Score on a scale of 27-30: normal; Score<27 points: cognitive dysfunction; 21-26, mild; 10-20, moderate 0-9; Severe
Measured: Baseline, months 3, 6
Assess changes in cognitive function by Montreal Cognitive Assessment
The total score of the scale is 30 points, and the test results show a normal value of ≥26 points.
Measured: Baseline, months 3, 6
Assess changes in anxiety by Self-Rating Anxiety Assess changes in anxiety by Self-Rating Anxiety Scale
The cut-off value of the SAS standard score is 50 points, of which 50-59 is mild anxiety, 60-69 is moderate anxiety, and 70 points or more is severe anxiety.
Measured: Baseline, months 3, 6,
Assess depressive mood changes by Self-rating depression scale Assess depressive mood changes by Self-rating depression scale 8/5000 Assess depressive mood changes by Self-rating depression scale
The dividing value of the SDS standard score is 53 points, with 53-62 being mild depression, 63-72 being moderate depression, and 73 points or more being severe depression.
Measured: Baseline, months 3, 6
Assess changes in memory and executive ability by memory and executive screening
Out of 100, the memory factor is 50, and the execution factor is 50. The 3 indicators of MES (memory score, execution score, and total score) correlated significantly with age, with older age scoring lower and no significant correlation with educational attainment.
Measured: Baseline, months 3, 6
Assess changes in cognitive function by auditory verbal learning test
-1.5SD (50-59 years: 4 points; 60-69 years old: 3 points; 70-89: 2 points); -1.0SD (50-59 years: 5 points; 60-69 years old: 4 points; 70-89:3 points)
Measured: Baseline, months 3, 6
Assess changes in cognitive function by Rey-Osterrieth complex figure
The total score is 36 points, and the lower the score, the worse it gets
Measured: Baseline, months 3, 6,
Assess changes in cognitive function by verbal fluency test
1 point is awarded for each correct one, and the number of correctly enumerated within 1 minute is the total score. ≥11 points are normal.
Measured: Baseline, months 3, 6,
Assess changes in cognitive function by shape trails test
Record the total number of elapsed and first-minute arrivals as well as the number of prompts one
Measured: Baseline, months 3, 6
Assess changes in cognitive function by StroopColor-WordTest
The amount of interference reflected includes: SIE time consumption = card C - card B time consumed: SIE correct number = card B - card C correct number, the larger the SIE indicates that the more severe the impairment of executive function.
Measured: Baseline, months 3, 6,
Assess changes in cognitive function by Clock Drawing Test
The total score is 30 points, CDT30-A is 4 out of 4, and ≤ 2 points are cognitive impairment; CDT30-B scored 26 out of 26, with ≤17 being rated as impaired cognitive function
Measured: Baseline, months 3, 6,
Assess changes in cognitive function by digit span test
Each correct answer is counted as 1 point for a string of numbers, and the total score = smooth back + reverse recitation.
Measured: Baseline, months 3, 6
Assess changes in cognitive function by symbol digit modalities test
The number of correctly filled in within 90s is the final score.
Measured: Baseline, months 3, 6
Assess changes in cognitive function by functional activities questionnaire
The total score is 30 points. A score of > 9 indicates social activity dysfunction.
Measured: Baseline, months 3, 6
Assess quality of life changes by Activity of Daily Living Scale
The total score is 80 points, the higher the score, the more impaired the ability to live a daily life
Measured: Baseline, months 3, 6
Assess changes in sleep quality by Pittsburgh sleep quality index
The total score ranges from 0~21, and the higher the score, the worse the sleep quality.
Measured: Baseline, months 3, 6
Changes in the intestinal flora
Intestinal microbiota detection using 16s rRNA technology
Measured: Baseline, months 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Huang, MD, Study director, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636670
- Sponsor's protocol ID
- NFEC-2022-417
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease: a Retrospective and Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05636670
- Acronym / sponsor ID
- NFEC-2022-417
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Dec 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.
Based on clinical manifestations, laboratory data and intestinal microflora detection, the cognitive function characteristics of patients with systemic lupus erythematosus and cerebrovascular disease and its relationship with intestinal microflora were analyzed to explore the possible pathogenesis of lupus cerebrovascular disease.
Detailed description
This study was a retrospective and prospective cohort study. They were divided into three groups, namely SLE group, SLE cerebrovascular disease group and healthy control group. Each group included 60 patients [Anticipated].
- Retrospective study: The SLE patients admitted to Nanfang Hospital from 2018 to 2022 were retrieved. The patients enrolled from September 2018 to September 2021 applied for exemption from informed consent, and the patients enrolled from September 2021 to September 2022 voluntarily signed informed consent. Patients were selected according to inclusion and exclusion criteria, and clinical and laboratory data of all subjects were recorded.
- Prospective study: Obtain the consent of the subjects, sign the informed consent, and record the clinical and laboratory examination data of all the subjects. (1) Cognitive function assessment; (2) Fresh stool and serum were collected, and 16s rRNA technology was used for intestinal flora detection, and QIIME2 platform was used for flora analysis; Serum inflammatory factors were detected and metabolomic analysis was performed.
The clinical data of all enrolled patients were statistically analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLE group | – | –1. The researcher signed the informed consent voluntarily; 2. Male or female patients aged 14-55 years; 3. Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019. 4. Patients who need to undergo head imaging examination according to the judgment of treating doctors, and the results of head imaging examination are not consistent with changes in cerebrovascular disease. 5. no antibiotics have been taken in the past 2 weeks; |
| NPSLE epilepsy group | – | –1. The researcher signed the informed consent voluntarily; 2. Male or female patients aged 14-55 years 3. Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019. 4. Patients who need MRI according to the judgment of the treating doctor, and reveal that the MRI suggests cerebrovascular disease; 5. no antibiotics have been taken in the past 2 weeks; |
| Healthy control group | – | –1. Male or female patient volunteers aged 14-55 from the Health Examination Center of Nanfang Hospital, 2. Voluntary signing of informed consent; 3. no systemic disease; 4. According to the judgment of the researchers, healthy volunteers matching SLE group in age, gender and education level were selected as the control group; |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Diagnostic criteria: Patients diagnosed with systemic lupus erythematosus are classified as SLE by the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019. Brain imaging cerebrovascular changes were defined as: great vascular lesions including cerebral infarction, cerebral hemorrhage, venous sinus thrombosis; Microvascular lesions include leukodystrophy, cerebral atrophy, perivascular space enlargement, lacunar infarction, cerebral microhemorrhage focus, and recent subcortical infarction.
Key inclusion criteria (21 listed)
- Retrospective study
- Patients enrolled from September 2018 to September 2021 applied for exemption from informed consent, and patients enrolled from September 2021 to September 2022 signed informed consent voluntarily.
- Male or female patients aged 14-55 years;
- Patients diagnosed with systemic lupus erythematosus are classified according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) joint classification criteria for SLE in 2019.
- Cranial imaging examination was performed, and the results of cranial imaging examination were consistent with cerebrovascular disease changes.
Key exclusion criteria (6 listed)
- Patients with other autoimmune diseases;
- Brain imaging suggested central nervous system infection, space occupation and other manifestations.
- Patients with malignant tumors and active tuberculosis;
- Pregnancy, lactation or intended pregnancy, women of childbearing age do not use effective contraceptive measures (IUD, oral contraceptives and obstruction measures);
- History of cerebrovascular disease not associated with SLE as determined by the investigator
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
Assess changes in cognitive function by Mini-mental State Examination
Time frame: Baseline, months 3, 6
Score on a scale of 27-30: normal; Score<27 points: cognitive dysfunction; 21-26, mild; 10-20, moderate 0-9; Severe
Assess changes in cognitive function by Montreal Cognitive Assessment
Time frame: Baseline, months 3, 6
The total score of the scale is 30 points, and the test results show a normal value of ≥26 points.
Assess changes in anxiety by Self-Rating Anxiety Assess changes in anxiety by Self-Rating Anxiety Scale
Time frame: Baseline, months 3, 6,
The cut-off value of the SAS standard score is 50 points, of which 50-59 is mild anxiety, 60-69 is moderate anxiety, and 70 points or more is severe anxiety.
Assess depressive mood changes by Self-rating depression scale Assess depressive mood changes by Self-rating depression scale 8/5000 Assess depressive mood changes by Self-rating depression scale
Time frame: Baseline, months 3, 6
The dividing value of the SDS standard score is 53 points, with 53-62 being mild depression, 63-72 being moderate depression, and 73 points or more being severe depression.
Assess changes in memory and executive ability by memory and executive screening
Time frame: Baseline, months 3, 6
Out of 100, the memory factor is 50, and the execution factor is 50. The 3 indicators of MES (memory score, execution score, and total score) correlated significantly with age, with older age scoring lower and no significant correlation with educational attainment.
Assess changes in cognitive function by auditory verbal learning test
Time frame: Baseline, months 3, 6
-1.5SD (50-59 years: 4 points; 60-69 years old: 3 points; 70-89: 2 points); -1.0SD (50-59 years: 5 points; 60-69 years old: 4 points; 70-89:3 points)
Assess changes in cognitive function by Rey-Osterrieth complex figure
Time frame: Baseline, months 3, 6,
The total score is 36 points, and the lower the score, the worse it gets
Assess changes in cognitive function by verbal fluency test
Time frame: Baseline, months 3, 6,
1 point is awarded for each correct one, and the number of correctly enumerated within 1 minute is the total score. ≥11 points are normal.
Assess changes in cognitive function by shape trails test
Time frame: Baseline, months 3, 6
Record the total number of elapsed and first-minute arrivals as well as the number of prompts one
Assess changes in cognitive function by StroopColor-WordTest
Time frame: Baseline, months 3, 6,
The amount of interference reflected includes: SIE time consumption = card C - card B time consumed: SIE correct number = card B - card C correct number, the larger the SIE indicates that the more severe the impairment of executive function.
Assess changes in cognitive function by Clock Drawing Test
Time frame: Baseline, months 3, 6,
The total score is 30 points, CDT30-A is 4 out of 4, and ≤ 2 points are cognitive impairment; CDT30-B scored 26 out of 26, with ≤17 being rated as impaired cognitive function
Assess changes in cognitive function by digit span test
Time frame: Baseline, months 3, 6
Each correct answer is counted as 1 point for a string of numbers, and the total score = smooth back + reverse recitation.
Assess changes in cognitive function by symbol digit modalities test
Time frame: Baseline, months 3, 6
The number of correctly filled in within 90s is the final score.
Assess changes in cognitive function by functional activities questionnaire
Time frame: Baseline, months 3, 6
The total score is 30 points. A score of > 9 indicates social activity dysfunction.
Assess quality of life changes by Activity of Daily Living Scale
Time frame: Baseline, months 3, 6
The total score is 80 points, the higher the score, the more impaired the ability to live a daily life
Assess changes in sleep quality by Pittsburgh sleep quality index
Time frame: Baseline, months 3, 6
The total score ranges from 0~21, and the higher the score, the worse the sleep quality.
Changes in the intestinal flora
Time frame: Baseline, months 3, 6
Intestinal microbiota detection using 16s rRNA technology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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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.
Qin Huang, MD study director
Southern Medical University, China
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 Lupus Erythematosus, Systemic and Gastrointestinal Microbiome, run by Nanfang Hospital, Southern 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 21 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 Dec 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 Huang Qin, MD (13632430850, qinzihq@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess changes in cognitive function by Mini-mental State Examination (time frame: Baseline, months 3, 6). The study lists 17 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 Dec 2022.