Psoriasis Vulgaris
Conditions
Interventions
Intervention group:fecal capsule
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Sex: No restrictions. (2) Age: 60-75 years old (including the boundary values). (3) Patients diagnosed with plaque psoriasis according to the "Guidelines for the Diagnosis and Treatment of Psoriasis in China (2022)". (4) Disease duration of at least 6 months and prior treatment with at least one topical medication, systemic medication, or phototherapy. (5) During the screening period, meeting at least one of the following criteria: BSA = 10%, PASI score = 10, DLQI score = 10. (6) Willing to sign an informed consent form, able to communicate effectively with the researchers, and willing to complete the study according to the protocol.
Exclusion criteria
Exclusion criteria: (1) History of malignant tumors or inflammatory bowel disease within the past 5 years (excluding cured cases of basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma). (2) Presence of other inflammatory skin diseases that may interfere with efficacy assessment. (3) Severe liver dysfunction with ALT elevation greater than twice the upper limit of normal, chronic renal insufficiency with eGFR < 60 ml/min/1.73m², uncontrolled serious cardiovascular, neurological, gastrointestinal, respiratory, hematological, endocrine, or other significant organ system diseases. (4) Two consecutive stool routine tests during initial screening showing leukocytes or positive occult blood, or tumor marker screening indicating elevated markers related to digestive system tumors. (5) Use of systemic medications such as fluorouracil, methotrexate, azathioprine, thiopurines, tacrolimus, cyclosporine, cyclophosphamide, Tripterygium wilfordii glycosides, or retinoids within the half-life period of the drug prior to the first transplantation. (6) Use of biologics for systemic treatment within the half-life period of the drug prior to the first transplantation or within 3 months (whichever is longer). (7) Undergoing ultraviolet light therapy within the past month. (8) Recent use of antimicrobial drugs, probiotics/preparations, interventions to regulate intestinal microbiota, or other medications with significant impact on gut microbiota within the past month. (9) Known active severe infectious diseases such as tuberculosis, hepatitis, CMV infection, EBV infection, etc. (10) Congenital immunodeficiency. (11) Anticipated difficulty in swallowing the study drug due to gastric or esophageal surgery or other conditions. (12) Substance abuse, alcoholism, or mental abnormalities that may hinder cooperation, adherence to treatment, or compliance prediction. (13) Participation in other clinical trial studies within the past 3 months. (14) Ineligibility based on the investigator's discretion due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the response rate of psoriasis area and severity index (PASI 75) between the intervention group and the control group at week 8 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in changes from baseline in the Psoriasis Area and Severity Index (PASI) scores at weeks 2, 4, and 8 between the intervention group and the control group.;The difference in changes from baseline in Body Surface Area (BSA), static Physician Global Assessment (sPGA), and Dermatology Life Quality Index (DLQI) scores at weeks 2, 4, and 8 between the intervention group and the control group.;The difference in response rates of PASI 50, PASI 75, and PASI 90 at weeks 2, 4, and 8 between the intervention group and the control group.; | — |
Countries
China
Contacts
Public ContactHongzhong Jin
Peking Union Medical College Hospital
Outcome results
None listed