Eczema
Conditions
Interventions
Placebo group:One placebo was administered orally twice daily for 4 consecutive weeks.
Positive control group:One sachet of lyophilized powder for the positive control group, containing three strains including *Lactobacillus rhamnosus* ATCC 53103, *Bifidobacterium animalis* subsp. *lact
High-dose FN041 group:TWO sachet of FN041(1×10^10CFU/strain) lyophilized powder was administered orally twice daily for 4 consecutive weeks.
Low-dose FN041 group:One sachet of FN041(1×10^10CFU/strain) lyophilized powder was administered orally twice daily for 4 consecutive weeks.
Sponsors
Changzhou Maternal and Child Health Care Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Aged 2–10 years; (45% of children develop the disease within 6 months, and 85% by the age of 5 years; J Am Acad Dermatol. 2000, 43: 649–655) 2. Children with eczema diagnosed according to the Williams criteria; 3. Able to provide skin and fecal samples; 4. Informed consent signed by the mother or legal guardian.
Exclusion criteria
Exclusion criteria: 1. Received antibiotic treatment within 4 weeks prior to enrollment; 2. Exposure to commercial probiotic products within the past 1 week; 3. Acute gastrointestinal infection; 4. Chronic diseases or potential infection risks, such as neurological disorders, metabolic diseases, chronic respiratory diseases, congenital abnormalities, etc.; 5. Known or suspected immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scoring Atopic Dermatitis;Eczema Area and Severity Index;Children’s Dermatology Quality of Life Index;Dermatitis Family Impact Questionnaire; | — |
Countries
China
Contacts
Public ContactHu Haiting
Changzhou Maternal and Child Health Care Hospital
Outcome results
None listed