This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
There is a screening period of about 2 weeks before the start of the test product. The subjects who meet the conditions of this test are randomly assigned according to the ratio of 1:1, and take the lactic acid bacteria NTU 101 or Placebo in the test group for a total of 12 weeks of treatment. Once, after the treatment, the test physician evaluated the safety and efficacy of the subjects taking the test group lactobacillus NTU 101 or Placebo. After the end of the treatment period, all subjects underwent a 2-week discontinuation follow-up period. This study will track subjects before and after taking samples, SCORing Atopic Dermatitis (Screen-Visit 4), Children's Dermatology Life Quality Index (Visit 1-Visit4), Patient-Oriented Eczema Measure (Visit 1-Visit4), to evaluate subjects Severity of illness. The subjects received the following tests before and after taking the samples: a full set of blood tests, leukocyte differential counts, serum biochemical tests (BUN, Creatinine, GOT, GPT), and collection of peripheral blood mononuclear cells and stool samples for analysis of the subjects immune function and gastrointestinal microbiota.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
One NTU 101 Lactic Acid Bacteria Vegetable Capsule a day for a total of 12 weeks. Product ingredients: microcrystalline cellulose, corn starch, NTU 101 Lactobacillus paracasei subsp. paracasei NTU 101 (1.8 x 10\^10 CFU); capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
Maltodextrin was used as a placebo
SCORing Atopic Dermatitis (SCORAD) Improvement Total Score
Compared with the placebo group, after taking probiotics or placebo for 4, 8, and 12 weeks, the atopic dermatitis severity score SCORAD in the control group improved by at least 30% or the ratio of subjects in the test group to the placebo groupPlacebo group According to the statistical method, there is a statistical difference in the total score of SCORAD improvement, at least reaching one of the two items.
Time frame: 12 weeks
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