Bullous pemphigoid
Conditions
Interventions
Placebo capsules group:Placebo capsules were added orally (about 30 capsules/time) at 0, 1, 2, 4 weeks for a total of 4 times of transplantation.
Fecal bacteria capsule group:Fecal bacteria capsules were added orally (about 30 capsules/time) at 0, 1, 2, 4 weeks for a total of 4 times of transplantation.
Sponsors
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) No gender limitation; (2) Older than 60 years old; (3) Meeting the diagnostic criteria of bullous pemphigoid in the Consensus on the Diagnosis and Treatment of Autoimmune subepidermal bullous Diseases (2022); (4) The baseline BPDAI active scoring 56 minutes or less, and satisfy the standard of activity: new three or more a month her lesions (such as blister sample, eczema or hives plaques), or at least a large new rash (> 10 cm in diameter), persists for more than 1 week, or the original skin increase from the previous/itching increase; (5)Patients with combined glucocorticoid-treated bullous pemphigoid were allowed if they had new or recurrent bullous pemphigoid with or without stable glucocorticoid use at a baseline dose of 0.5mg/kg prednisone equivalent per day or less. Note: Subjects taking oral glucocorticoids were considered to be taking a stable dose if there was no change in the daily dose of the hormone during the 14 days before baseline. (6) signed informed consent form and be willing and able to comply with all the visit plan, treatment, laboratory examination, lifestyle considerations and other research programs.
Exclusion criteria
Exclusion criteria: (1)Received immunosuppressive therapy (including but not limited to methotrexate, cyclophosphamide and cyclosporine, azathioprine, mycophenolate mofetil) or dapsone within 1 month before the first dose of the trial drug or within 5 half-life periods of the drug, whichever was longer; (2) Within a month before the test drug delivery for the first time used antimicrobial drug, probiotics/yuan preparation and regulating intestinal microecological treatment and the other has a larger effect on intestinal flora of drugs; (3) Good single treatment using history or accept excessive split, especially a resistance within three months, and other biological agents treatment; (4) The experimental drug 14 days before the first delivery or five drug half-life time (the time elders shall prevail) used may interfere with the efficacy evaluation of some other drugs (except stable with disease medication) or treatment; (5) Patients with serious heart, brain, lung, liver, kidney, blood and other important organ system diseases, who were considered by the investigators to be not suitable for participation in the study; (6) With malignant tumor or a history of malignancy within five years before screening (not including thyroid papillary carcinoma or basal cell carcinoma of the skin). (7) Pregnant or pre-pregnant or lactating women; (8) Currently known active TB, active or recurrent severe infections such as active hepatitis patients; (9) Drug and alcohol abuse, or mental abnormalities, unable to cooperation or not adhere to the treatment and predict poor compliance of patients; (10) Patient is at the same time to participate in other clinical trials; (11) Anyone who for other reasons considered by the investigator to be unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving clinical remission (CR) at week 8 of treatment;The dose of hormones at the time the subject reached CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving CR at weeks 1, 2, 4, and 12;Time to CR in the subject;Subjects achieved the proportion of DC at weeks 1, 2, 4, 8, and 12;Participants were time and achieve the DC to DC doses of the hormone;The subjects of DC or CR participants during the study of the cumulative dose of hormone;Subjects disease during the study period (at DC were nearly four weeks 3 or higher new lesions, not spontaneous healing in 1 weeks, or existing lesions extension) earlier time and proportion;Changes from baseline in BPDAI, DLQI, ABQOL, and IGA scores at 1, 2, 4, 8, and 12 weeks;Changes in anti-BP180 antibody titers from baseline at weeks 4, 8, and 12;At 0, 1, 2, 4, 8 and 12 weeks, the changes of oral, skin and intestinal flora, the proportion of lymphocyte subsets and the changes of serum effector cytokines (such as IL-17, IL-21, IL-2, IL-10) were observed;The improvement of clinical symptoms such as skin lesions, pain and pruritus of the subjects at each visit point; | — |
Countries
China
Contacts
Public ContactLu Qianjin
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Outcome results
None listed