psoriasis
Conditions
Interventions
Two:Placebo+original treatment regimen
Probiotic treatment group:Probiotic food + original treatment plan
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed consent, voluntary participation, and signed informed consent; 2) Have not lived abroad for nearly 1 year, aged 18-60 years old, including the boundary value; Gender is not limited, body mass index (BMI) between 18.5 and 35, including the boundary value; 3) Patients diagnosed with psoriasis vulgaris with a course of disease greater than 6 months, psoriasis vulgaris with BSA involvement at screening and baseline < 10%, PASI score < 10. PASI score decreased by less than 75% after 4 weeks of standardized treatment with IL-17A biologic agents (exumab and eicizumab). 4) Have not received probiotic therapy in the last 3 months.
Exclusion criteria
Exclusion criteria: 1) Receiving IL-17A biologic, PASI score decreased by 75% or more. 2) During screening, laboratory examination results showed the following abnormalities: a. hemoglobin < 100 g/L; b. White blood cell (WBC) count < 3.5 x 109 / L; c. Platelet < 100 x 109 / L; d. serum creatinine exceeding 1.5 times the upper limit of normal in the laboratory where the test was performed; e. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) exceed the upper limit of normal values by 2.5 times in the laboratory where the tests are performed; 3) Abnormal blood glucose and lipids: fasting blood glucose =6.1mmol/L (110mg/dl) or TG (triglyceride) =1.7mmol/L (150mg/dl), and/or HDL-C (high-density lipoprotein cholesterol) < 0.9mmol/L (male) or 1.1mmol/L (female); 4) Subjects with symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric, or brain diseases, or with other chronic diseases that are not eligible for participation in this clinical trial; 5) There is any serious systemic or local infection; 6) Having unstable cardiovascular disease, defined as having had clinical exacerbations in the last 3 months (e.g. unstable angina, rapid atrial fibrillation) or having been hospitalized for heart disease in the last 3 months; 7) Patients with unstable or uncontrollable hypertension need to be excluded. If the patients can control the stability through drug treatment, they can continue to be enrolled after the researchers' judgment; 8) Patients with significant abnormalities in heart rate, electrocardiogram (ECG) and respiratory system, which are judged by researchers as clinically significant; 9) A history or symptoms of malignancy, regardless of treatment, and regardless of signs of local recurrence or metastasis; 10) Subjects with a history of depression or who are clinically considered to be at risk of suicide; 111) Received systematic drug therapy, antibiotics, steroids, Chinese herbal preparations and other preparations that may affect digestive tract flora one month before enrollment; Received topical medication within 2 weeks before enrollment; 12) Taking food containing probiotics (such as lactic acid bacteria, bifidobacteria, etc.) (such as yogurt, Girolato, rice wine, etc.) in the week before enrollment; 13) Have a history of severe allergic reactions or are allergic to two or more kinds of food or drugs; 14) Women who are pregnant, breastfeeding or planning to become pregnant during the trial; 15) Participated in other clinical trials within 3 months before enrollment; 16) After clinical evaluation, the investigator considered that he could not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician's Global Assessment;body surface area;Dermatology Life Quality Index;Anxiety and Depression Rating Scale (patient self-assessment); | — |
Countries
China
Contacts
Public ContactZhu Wu
Xiangya Hospital Central South University
Outcome results
None listed