Systemic Lupus Erythematosus
Conditions
Interventions
Experimental group:Add fecal microbiota transplantation (FMT) capsules to original treatment
Control Group:Add placebo capsules to original treatment
Sponsors
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old (including 65 years old); 2. Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE diagnostic classification criteria, exclude infections, tumors and other connective tissue diseases and diagnose SLE patients; 3. During the screening period, the Systemic lupus erythematosus disease activity index-2000 (SLEDAI-2K) score =6 points; British Isles Lupus Assessment Group score-2004 (British Isles Lupus Assessment Group, BILAG-2004 ) results of severe disease activity in =1 organ/system (score A), or moderate disease activity in =2 organs/system (score B); and at least 1 definite autoantibody test result was positive, including ANA (titer = 1:80) and/or anti-dsDNA antibody and/or anti-Smith antibody. 4. Has received one or more of the following systemic standard treatments allowed by the study protocol: Oral glucocorticoid (prednisone no more than 0.5 mg/kg/d or equivalent drug) treatment for = 8 weeks before the first transplant in the study, and received stable doses of treatment for = 4 weeks. Received antimalarial therapy for = 8 weeks prior to study first transplant and received stable doses of therapy for = 6 weeks, including hydroxychloroquine =400 mg/day, or chloroquine =250 mg/day. If one or more of the following immunomodulators are used, they must have been treated for = 12 weeks prior to study initiation and received a stable dose for = 6 weeks; mycophenolate mofetil oral (MMF) =2 g/day or mycophenolic acid ( MPA) =1.92 g/day; methotrexate (MTX) orally =15 mg/week, combined with folic acid or folinic acid; azathioprine (AZA) =2 mg/kg/day; cyclosporine =250 mg/day ; Tacrolimus=4 mg/day; Leflunomide = 20 mg/day; discuss the appropriateness of the subject's participation in the research; 5. Those who signed the informed consent form voluntarily participated in this project and were able to complete the follow-up as required.
Exclusion criteria
Exclusion criteria: 1. There is severe active lupus nephritis: single urine protein/creatinine ratio (UPCR)>3.0mg/mg (proteinuria>3.0g/24h), or have BILAG A lupus nephropathy, or have required hemodialysis or have red blood cell tube type of active urinary sediment, or histological evidence of diffuse proliferative glomerulonephritis within 12 weeks prior to screening (if any); 2. The presence of any unstable or active CNS lupus (eg, seizures, acute confusional states, myelitis, stroke or stroke syndrome, SLE-related cerebellar ataxia or dementia, CNS vasculitis, etc.) ; 3. Subjects with clinical laboratory examinations at screening showing any of the following abnormalities: hemoglobin <8 g/dL (<80 g/L); absolute neutrophil count (ANC) <1.2 x 10 ^9/L (<1200mm3); absolute lymphocyte count (ALC) <0.75x10^9/L (<750/mm3); platelet count <50 x 10^9/L (50,000/mm3) (Note: If the investigator believes that the above 4 conditions are the result of SLE, and exclude malignant tumor, serious infection, congenital immunodeficiency, other autoimmune or inflammatory diseases and other diseases of the vital organ system, consult with the medical monitor. Subjects may participate in the trial after discussion with the sponsor and/or the medical monitor regarding the appropriateness of the subject's participation in the study); estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 based on age-appropriate calculations; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value =2 times the upper limit of normal (ULN); total bilirubin =1.5 times ULN (Note: If the laboratory test results are abnormal during the screening period, the test can be repeated once during the 4-week screening period to confirm the abnormal results. Subjects may enter the study if the results return to normal within the 4-week screening period); 4. Suffering from malignant tumor or a history of malignant tumor within 5 years before screening; 5. There are other inflammatory diseases that may interfere with the evaluation of efficacy, including but not limited to rheumatoid arthritis (RA), overlap syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease or active Lyme sick; 6. Patients with serious heart, brain, lung, liver, kidney, blood and other important organ system diseases, and the researchers believe that they are not suitable to participate in this study; 7. Received cyclophosphamide, biological agents, such as tocilizumab, alfacet, efalizumab within 5 drug half-lives or within 3 months (whichever is longer) before the first transplant in the study , natalizumab, abatacept, anakinra, Brodalumab, secukinumab, Ixekizumab, or targeting tumor necrosis factor alpha (TNF-a), IL-1, LL-6, IL- 17 or inhibitors of the IFN pathway; 8. Those who have used antimicrobial drugs, probiotics/meta-preparations, treatment of regulating intestinal microecology and other drugs that have a greater impact on intestinal flora within 2 months; 9. Known active or recurrent serious infection such as active tuberculosis; 10. Congenital immunodeficiency or congenital immunosuppression; 11. Patients with drug addiction, alcohol abuse or mental disorders, unable to cooperate or adhere to treatment, and poor predictability of compliance; 12. Pregnant women, pregnant women and lacta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLE Responder Index (SRI-4); | — |
Secondary
| Measure | Time frame |
|---|---|
| Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K);Physician's Global Assessment (PGA);Improvement of clinical symptoms;Decreased glucocorticoid dose;Time to first severe relapse;Laboratory testing;Changes in immunological parameters;BICLA(British Isles Lupus Assessment Group–based Composite Lupus Assessment) response; | — |
Countries
China
Contacts
Public ContactLu Qianjin
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed