Target disease: Atopic dermatitisClinical manifestations: Polymorphic skin lesions, severe pruritus, and frequent recurrence
Conditions
Interventions
Control group:Standard conventional therapy
Intervention group:Fecal microbiota transplantation combined with standard basic therapy
Sponsors
Fujian Children’s Hospital, Fujian, China
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Subjects meeting the above diagnostic criteria for atopic dermatitis and the definition of moderate-to-severe disease; 2. Aged 5–16 years, with no restriction on gender; 3. The informed consent procedure shall comply with relevant regulations; informed consent shall be signed by legal guardians together with participating children aged = 8 years.
Exclusion criteria
Exclusion criteria: 1. Active infections: active tuberculosis, severe viral infections, acute gastrointestinal infections, etc.; 2. Immune disorders: congenital or acquired immunodeficiency; 3. Recent medication history: systemic therapies including glucocorticoids, immunosuppressants, biologics, antibiotics or probiotics administered within the past 4 weeks; medium/high-potency topical glucocorticoids or topical calcineurin inhibitors (TCI) used within 2 weeks prior to screening; antihistamines taken within 1 week prior to screening; 4. Contraindications to FMT: confirmed history of adverse reactions to FMT or its preparation components; severe structural gastrointestinal diseases (e.g., active inflammatory bowel disease); 5. Other conditions: any other conditions judged inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EASI-75 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in blood routine eosinophil counts, Th2-related inflammatory markers (IL-4, IL-5, IL-13), IL-31, CCL17, and serum total IgE levels before and after treatment;Changes in assessment indicators for children complicated with asthma and those complicated with rhinitis;Changes in Peak Pruritus Numeric Rating Scale (PP-NRS);Changes in Investigator’s Global Assessment (IGA) score;Changes in SCORAD score;Changes in intestinal flora structure, diversity and related metabolites before and after treatment;Changes in Children's Dermatology Life Quality Index (CDLQI) scores; | — |
Countries
China
Contacts
Public ContactChen Jie
Fujian Children’s Hospital, Fujian, China
Outcome results
None listed