Intestinal microbiota transplantation for the treatment of systemic lupus erythematosus
Conditions
Interventions
Group A:Intestinal microbiota transplantation
control D:placebo
Group B:Intestinal microbiota transplantation
Group C:Intestinal microbiota transplantation
Sponsors
Wuxi No.2 People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria for patients with systemic lupus erythematosus: ? Age above 18 years; ? Patients diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE diagnostic classification criteria; ? Received at least 6 months of standard treatment, including corticosteroids, immunosuppressants, etc., without effective control of symptoms; ? Patients voluntarily participate in the treatment of intestinal flora transplantation and sign an informed consent form; ? The patient has not received intestinal flora transplantation therapy. ? Conscious and able to communicate normally verbally. 2.Fecal bacteria donor inclusion criteria: ? Healthy women aged 18 to 30 years old, no bacterial or fungal infectious diseases in the intestinal tract in the past three years, and healthy work and rest, no bad habits such as staying up all night, and no application of antibiotics in the past 6 months; ? No history of drug and food allergies, no history of long-term medication; ? No underlying diseases, no autoimmune diseases, parasitic infections and other disease states. ? No any of the conditions in the exclusion criteria.
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria for patients with systemic lupus erythematosus: ? Active severe lupus nephritis, active central nervous system lupus, active infection; ? the existence of other inflammatory diseases that may interfere with the evaluation of the efficacy of treatment, including but not limited to rheumatoid arthritis, psoriasis, dermatomyositis, multiple sclerosis, overlap syndrome, Crohn's disease; ? 2 months have used anti-microbial drugs, probiotics / meta-preparation and regulation of intestinal microecological therapy and other drugs that have a greater impact on the intestinal flora; ? Suffering from serious cardiovascular and cerebrovascular diseases, respiratory system diseases, immune system diseases and serious liver and kidney damage; ? Participation in other clinical trials within 3 months, history of malignancy or other inflammatory diseases and selected laboratory abnormalities; ? Women preparing for pregnancy, pregnant women and nursing mothers; ? Suffering from severe psychiatric disorders, such as depression and generalised anxiety disorder; ? Patients with allergic reactions to intestinal flora transplantation therapy; ? Patients who fail to provide complete medical history or examination information; ? Patients who are unable to undergo the various tests required for this study for various reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine and rapid CRP;spectrum of antinuclear antibodies;rheumatological factor;sex hormone;blood sedimentation;routine urine test;stool for routine;16S rRNA sequencing;Basic data of patients;mass spectrum identification; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver function;renal function;glycated haemoglobin;C-reactive protein;blood lipid; | — |
Countries
China
Contacts
Public ContactFeng Ninghan
Wuxi No.2 People's Hospital
Outcome results
None listed