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Recruiting NCT05636670

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

Conditions: Lupus Erythematosus, Systemic, Gastrointestinal Microbiome

Sex: All
Ages: 14 Years – 55 Years
Healthy volunteers: 1
Enrollment: 180
Sponsor: Nanfang Hospital of Southern Medical University

Location: China

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.

Eligibility Criteria

Inclusion Criteria:Retrospective studyPatients 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 groupThe researcher signed the informed consent voluntarily;Male or female patients aged 14-55 yearsPatients 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 investigatorThe researcher judged that it is not suitable to participate in this researcher.

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Source: ClinicalTrials.gov (NCT05636670). StuddyBuddy aggregates publicly available trial information.