Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease

Lupus Erythematosus, Systemic Clinical Trial

Official title:

Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease: a Retrospective and Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636670
• Other study ID #: NFEC-2022-417
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Huang Qin, MD
• Phone: 13632430850
• Email: qinzihq[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 cerebrovascular disease.

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]. 1. 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. 2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

Inclusion Criteria:

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:

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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Gastrointestinal Microbiome
• Lupus Erythematosus, Systemic

Locations

Country	Name	City	State
China	Qin Huang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, months 3, 6
Primary	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.	Baseline, months 3, 6
Primary	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.	Baseline, months 3, 6,
Primary	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.	Baseline, months 3, 6
Primary	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.	Baseline, months 3, 6
Primary	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)	Baseline, months 3, 6
Primary	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	Baseline, months 3, 6,
Primary	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.	Baseline, months 3, 6,
Primary	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	Baseline, months 3, 6
Primary	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.	Baseline, months 3, 6,
Primary	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	Baseline, months 3, 6,
Primary	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.	Baseline, months 3, 6
Primary	Assess changes in cognitive function by symbol digit modalities test	The number of correctly filled in within 90s is the final score.	Baseline, months 3, 6
Primary	Assess changes in cognitive function by functional activities questionnaire	The total score is 30 points. A score of > 9 indicates social activity dysfunction.	Baseline, months 3, 6
Primary	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	Baseline, months 3, 6
Primary	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.	Baseline, months 3, 6
Primary	Changes in the intestinal flora	Intestinal microbiota detection using 16s rRNA technology	Baseline, months 3, 6