psoriasis
Conditions
Interventions
treatment group:FMT+external medical emollient
placebo group:gastrointestinal endoscopy and normal saline injection + external medical emollient
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) subjects will voluntarily participate in the study, sign a written informed consent, and comply with the study requirements; (2) male or female aged at least 18 years; (3) patients with moderate-to-severe chronic plaque psoriasis were defined as follows at baseline: BSA at least 10%, PASI at least 12; (4) poor control by local treatment and/or phototherapy and/or previous systemic treatment; (5) patients with chronic constipation for at least 6 months or chronic diarrhea for at least 2 months.
Exclusion criteria
Exclusion criteria: (1) suffering from other skin diseases except psoriasis; (2) suffering from psoriasis other than plaque psoriasis; (3) suffering from drug psoriasis; (4) received nb-uvb treatment within two months or did not want to stop phototherapy during the study period; (5) used other external medicine treatment for psoriasis other than medical emollients within 1 month; (6) received systemic therapy for psoriasis (glucocorticoids, immunosuppressants, retinoic acid derivatives, etc.) within two months; (7) exposure to biological agents within 6 months; (8) is using other experimental drugs or is in 5 times half-life period or within 30 days (whichever is the older); (9) those who have received immunomodulator treatment within 1 year; (10) pregnant, pregnant and lactating women; (11) in addition to psoriasis, there is a history of other serious systemic progressive diseases (such as history of active inflammatory diseases, history of chronic or recurrent progressive infectious diseases, and history of malignant diseases, etc.); (12) concomitant: (1) significant medical problems, including, but not limited to, uncontrolled hypertension (systolic blood pressure 160mmHg and/or diastolic blood pressure 95mmHg), congestive heart failure (New York heart association status class III or IV). The serum creatinine level exceeded 2.0mg/dl (176.8 mol/L).White blood cell count <2500/l or platelet <100000 / l or neutrophil <1500 /l or hemoglobin <8.5g/dl at the time of screening; (13) have used anti-microbial drugs, probiotics, intestinal microecological regulation therapy, high-dose vitamins and other pharmacological treatments that have a greater impact on intestinal flora within 1 month; (14) congenital immune deficiency or low immunity; (15) surgery for other diseases within 2 months or may be required; (16) for any other reason, the researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI and BSA;SF-36 scale +DLQI scale;adverse reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Structure and diversity of faeces, intestinal mucosa and skin microflora;Immunological indicators;Cytological index;Skin histopathology and immunohistochemistry; | — |
Countries
China
Contacts
Public ContactHua Zhao
Department of Dermatology, PLA General Hospital
Outcome results
None listed