Pemphigus
Conditions
Interventions
Experimental group:Fecal bacteria capsules
Sponsors
Hospital for Skin Diseases(Institute of Dermatology)Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. No gender limit. 2. Age > 18 years. 3. Fulfill the diagnostic criteria of pemphigus in the Expert Recommendations for Diagnosis and Treatment of Pemphigus Vulgaris (2020); 4. PDAI activity score <= 45 at baseline and the pemphigus are in the activity period: In two weeks, there are 3 or more new lesions that do not heal spontaneously within 1 week appearing or the established lesions extending. 5. Newly diagnosed or recurrent pemphigus patients with or without the treatment of a stable dose of glucocorticoids are admitted to this clinical trial and the dosage of the glucocorticoids must be less than 0.5mg/kg/day prednisone equivalent at baseline. (Note: If the participants have been treated with glucocorticoid at baseline, the dosage of glucocorticoid must have not been changed during 2 weeks before baseline) 6. Sign the informed consent form, voluntarily participate in this project, and can complete the follow-up as required.
Exclusion criteria
Exclusion criteria: 1. History of taking immunosuppressants (including but not limited to methotrexate, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil) or dapsone within 1 month or 5 half-lives of the drug (whichever is longer, which one will be taken as the standard); 2. History of taking antimicrobial drugs, probiotics, prebiotic preparations, or other treatments that regulate or have a significant impact on intestinal microbiome within 1 month; 3. History of treatment with Rituximab; 4. History of taking some drugs (except for stable concomitant drugs) within 14 days or 5 half-lives (whichever is longer, which one will be taken as the standard) that may interfere with the efficacy evaluation of the trial drug ; 5. Patients with serious diseases of heart, brain, lung, liver, kidney, blood or other important organ system, and the researchers believe that they are not suitable to participate in this study; 6. Patients suffering from malignant tumor or a history of malignant tumor within 5 years before screening(except for papillary thyroid carcinoma or basal cell carcinoma of the skin); 7. Pregnant or breastfeeding women and women preparing for pregnancy; 8. Patients suffering from known active or recurrent serious infection such as active tuberculosis or active hepatitis and so on; 9. Patients with drug addiction, alcohol abuse, or mental disorders, unable to cooperate or adhere to treatment, and with poor predictability; 10. Patients also participating in other clinical trials at the same time; 11. Patients deemed unsuitable to participate in this trial by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of clinical remission;Dosage of glucocorticoid;Rate of disease control;Time of disease control;Rate of disease relapse;Time of disease relapse;Pemphigus disease area index(PDAI) score;Dermatology life quality index(DLQI) score;Autoimmune bllous disease quality of life questionnaire(ABQOL);Investigator global assessment(IGA)score;Improvement of clinical symptoms and signs;Laboratory testing;Changes in immunological parameters;Changes in microbiota; | — |
Countries
China
Contacts
Public ContactSuying Feng
Hospital for Skin Diseases(Institute of Dermatology)Chinese Academy of Medical Sciences, Peking Union Medical College
Outcome results
None listed