The primary objective of this trial is to assess the efficacy of the consumption of heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
126
Kaohsiung Municipal TA-TUNG Hospital
Kaohsiung City, Qianjin District, Taiwan
Kaohsiung Municipal Hsiao-Kang Hospital
Kaohsiung City, Siaogang District, Taiwan
Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation
Taipei, Songshan District, Taiwan
Chung Shan Medical University Hospital
Taichung, South District, Taiwan
Change from Baseline SCORAD Score at 16 weeks of treatment
SCORAD documented during the longitudinal observational period of 16 weeks after the subject has enrolled
Time frame: between 0 and 16 weeks of treatment
Score A, B and C of the SCORAD
Score A, B and C of the SCORAD The scores A, B and C of the SCORAD as well as the subcategories of the scores B and C will be analyzed separately (measured at V0c, V1, V2 and V3)
Time frame: 0, 4, 10 and 16 weeks of treatment
Number and duration of atopic dermatitis episodes
Number and duration of atopic dermatitis episodes The number of episodes of atopic dermatitis and the total number of days with symptoms during the 16 weeks intervention period
Time frame: during the 16 weeks intervention period
Transepidermal water loss
TEWL will be measured at V0, V1, V2 and V3 on 4 sites of both non-lesional and lesional appearing skin parts
Time frame: 0, 4, 10 and 16 weeks
Topical treatment used
Topical treatment used (sparing effect) The corticoid sparing effect of the ingredient will be assessed in the placebo and the ingredient group.
Time frame: during the 16 weeks of treatment
total and specific IgE
total and specific IgE
Time frame: 0 and 16 weeks
Quality of Life
The infants' dermatitis quality of life index (IDQOL) will be collected
Time frame: 0, 4, 10, 16 weeks and 1 and 4 years later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Linkou Chang Gung Memorial Hospital
Gueishan Township, Taoyuan County, Taiwan
Cardinal Tien Hospital
New Taipei City, Xindian District, Taiwan
assess the effect of the product on the safety parameters
Biochemistry and Hematology parameters
Time frame: 0 and 16 weeks
"Objective" SCORAD, which is composed of part A and B of the SCORAD (measured at V0, V1, V2 and V3)
Time frame: 0, 4, 10 and 16 weeks