atopic dermatitis
Conditions
Interventions
Placebo capsules:On the basis of the original background treatment, placebo capsules were added orally (about 30 capsules/time, once a week) for a total of 5 times of transplantation.
Fecal bacteria capsule:On the basis of the original background treatment, oral fecal bacteria capsule were added (about 30 capsules/time, once a week) for a total of 5 times.
Sponsors
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) gender not limited; (2) age =60 years old; (3) meet Hanifin - Rajka diagnostic criteria (see appendix 1), excluding infection, tumor, such as blister disease and diagnosis of AD patients. (4) EASI score =12 during screening; (5) signed the informed consent form, volunteered to participate in the project and completed the follow-up as required.
Exclusion criteria
Exclusion criteria: (1) with malignant tumours or five years before the screening of a history of malignancy. (2) The presence of other inflammatory skin diseases that may interfere with the efficacy evaluation, including but not limited to psoriasis, parapsoriasis, hypereosinophilic dermatitis, seborrheic dermatitis, contact dermatitis, etc. (3) 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. (4) received systemic treatment with steroids, tripterygium wilfordii, cyclosporine, methotrexate and traditional Chinese medicine 1 month before the first study transplantation. Treatment with a biologic agent or a JAK inhibitor was received within 5 or 3 months, whichever was longer, before the first study transplantation. (6) Use of systemic antimicrobial drugs, probiotics/protobiotics, intestinal microecological therapy, and other drugs that have a great impact on intestinal flora within 1 month. (7) patients with known active or recurrent severe infection such as active tuberculosis. (8) patients with drug abuse, alcohol abuse or mental disorders, unable to cooperate or adhere to treatment, or predicted poor compliance; (9) patients participated in other clinical trials within a month. (10) anyone who for other reasons considered by the investigator to be unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EASI 50 and 75; | — |
Secondary
| Measure | Time frame |
|---|---|
| EASI,SCORAD,IGA,ADCT,DLQI,PP-NRS,VAS,POEM,HADS at 2, 4, and 8 weeks;changes in SCORAD score from baseline to week 8;Changes in the proportion of Th cell subsets and serum effector cytokines in patients at 4, 8 and 12 weeks after treatment.;The decrease of total IgE in the 12th week.;At 2, 4, 8, and 12 weeks, the laboratory indexes of blood, urine, liver and kidney function, and electrolytes were improved.;Safety was evaluated at week 2, 4, 8 and 12, including the occurrence time and maintenance time of adverse reactions (such as upper abdominal discomfort, nausea, vomiting, diarrhea, constipation, abdominal distension, abdominal pain, fever, etc.) after transplantation.; | — |
Countries
China
Contacts
Public ContactLu Qianjin
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences
Outcome results
None listed