pemphigus
Conditions
Interventions
probiotics group:bifidobacterium
placebo group:placebo
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years old, male or female; (2) according to the 2020 Diagnosis and management of pemphigus: Recommendations of the an international panel of experts ", and 2020 Expert Recommendations for the Diagnosis and Treatment of pemphigus vulgaris Diagnostic criteria: pemphigus vulgaris or pemphigus erythematosus; (3) First onset or recurrence after traditional treatment; (4) During screening, disease activity meeting Pemphigus disease area index (PDAI) score 0<PDAI<8 or body surface area score (BSA) <10% was considered mild; 8=PDAI<24 or BSA 30%-50% for moderate; (5) The subjects have signed informed consent and are able to comply with the clinical study protocol.
Exclusion criteria
Exclusion criteria: (1) Antibiotics, probiotics/probiotics, intestinal microecological therapy and other drugs that have a greater impact on intestinal flora have been used within 3 months; (2) lactose intolerance; (3) Have malignant tumors or have a history of malignant tumors within 5 years prior to screening; (4) The presence of other autoimmune, inflammatory and digestive diseases that may interfere with the evaluation of efficacy, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, overlapping syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease, etc.; (5) Clinically significant cardiovascular, neurological, psychiatric, metabolic, liver, or other pathological conditions that may affect the interpretation of study results and/or the safety of study subjects; (6) Currently known to have active or recurrent serious infections such as tuberculosis and hepatitis; (7) Congenital immune deficiency or congenital low immunity; (8) Patients with drug, alcohol or mental disorders, unable to cooperate or adhere to treatment, and poor compliance; (9) Have a history of hypersensitivity or anaphylactic shock to any investigational drug or its excipients or similar chemical class drugs; (10) Systemic treatment of pemphigus with immunosuppressants such as cyclosporine, morpheolate, methotrexate, etc. 4 weeks before baseline visit; (11) Treatment with biologics within 4 weeks before baseline visit; (12) Patient participation in planned surgical procedures during the study period; (13) Women preparing for pregnancy, pregnancy or lactation (lactation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of Pemphigus antibody Antibody Dsg1;The level of Pemphigus antibody Antibody Dsg3;BSA;PDAI;DLQI;The dosage of glucocorticoids; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in population abundance and diversity of gut microbiota;Inflammatory factors IL-6, IL-10, CRP, TNF-a, Changes in immunoglobulin IgA, IgM, IgG, IgE and complement C3/C4 levels; | — |
Countries
China
Contacts
Public ContactGuiying Zhang
The Second Xiangya Hospital of Central South University
Outcome results
None listed