Psoriasis vulgaris
Conditions
Interventions
Experimental group:Oral fecal microbial transplant capsules
Sponsors
Hospital for Skin Diseases and Institute of Dermatology, Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Gender unlimited; 2. 18-65 years old; 3. Patients who were diagnosed by two dermatologists as psoriasis vulgaris according to the guidelines for the diagnosis and treatment of psoriasis in China (2018); 4. Throughout the screening period, BSA >= 10%, PASI >= 12 points, SPGA >= 3 points; 5. Patients who have received one or more of the following treatments but still have no significant remission: (1) Treated with oral antihistamines ; (2) Treated with oral acitretin/methotrexate maintenance treatment >= 8 weeks, and the dose of acitretin/methotrexate remains unchanged >= 4 weeks; (3) Treated with topical glucocorticoids, vitamin D3 derivatives, calcineurin inhibitors, retinoids, keratoplastics, PDE4 inhibitors, and benvitimod; (4) Treated with topical moisturizers.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of malignant tumor / inflammatory bowel disease within 5 years; 2. Patients who suffer from other inflammatory skin diseases that may disturb the efficacy evaluation, which include but not limited to atopic dermatitis, eosinophilic dermatitis, seborrheic dermatitis, contact dermatitis, etc; 3. Patients who suffer from chronic renal insufficiency with creatinine clearance rate 1.5mg/dl, child-Pugh C liver disease, severe cardiovascular, neurological, respiratory, blood, endocrine or other severe systemic diseases; 4. Patients who receive oral tacrolimus, systemic biological agents or NB-UVB irradiation within 5 half-life or drugs or 3 months (whichever is longer) before the first transplantation of the study; 5. Patients who receive anti-microbial agents, probiotics or other drugs that may have a great impact on intestinal flora within 2 months; 6. Patients who received oral Tripterygium wilfordii or cyclosporine A within 1 month; 7. Patients who suffer from active/recurrent serious infections such as active tuberculosis; 8. Patients with congenital immunodeficiency; 9. Patients with drug abuse, alcoholism or mental disorders, unable to cooperate with transplantation treatment; 10. Pregnant or lactating women; 11. Patients who already participates in other clinical trials at the same time; 12. Patients who are not appropriate to participate in this clinical trial for any another reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body surface area;Dermatology Life Quality Index;Static Physician's Global Assessment;Visual analogue scale; | — |
Countries
China
Contacts
Public ContactMin Li
Hospital for Skin Diseases and Institute of Dermatology, Chinese Academy of Medical Science
Outcome results
None listed