The clinical trial will be carried out in China Medical University Hospital. The overall plan is a double-blind trial. All recruited 3 months-3 years old atopic dermatitis (AD) patients are divided into two groups, 50 in each group and 100 in two groups. The two groups are placebo and Bifidobacterium longum CCFM1029. The entire evaluation plan lasts for 3 months. The number of probiotic bacteria is 5 billion per capsule, and the number of bacteria taken by the subjects is 5 billion per day (one capsule before bed each day). During the planning period, the eczema area and severity index (EASI) score of the patient's dermatitis was evaluated every month, and the score differences of dermatitis before and after taking probiotics was observed. In addition, subjects must perform two fecal samplings before and after the trial, and the isolated DNA was analyzed using the next-generation high-throughput sequencing method (NGS) for subject fecal flora changes. Comparing the two groups before and after taking the capsule, whether the intestinal flora changed. Statistical analysis of the relationship between changes in intestinal flora and the degree of AD. Through the above test, the investigators evaluated whether Bifidobacterium longum CCFM1029 can regulate the pediatric intestinal flora and relieve the inflammatory response in the body, thereby regulating atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Subjects take one capsule containing Bifidobacterium longum CCFM1029 daily at bedtime.
Subjects take one capsule containing maltodextrin daily at bedtime.
Glac Biotech Co., Ltd.
Tainan, Taiwan
Changes in eczema area and severity index (EASI) scores.
Changes in eczema area and severity index (EASI) scores were assessed before and 3 months of intervention. The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.
Time frame: Before and 3-month intervention.
Changes in eczema area and severity index (EASI) scores.
Changes in eczema area and severity index (EASI) scores were assessed after 1 month and 2 months of intervention. The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.
Time frame: After 1 month and 2 months of intervention.
Changes in gut microbiota ratios.
Changes in gut microbiota ratios were assessed by NGS before and 3 months of intervention.
Time frame: Before and 3 months of intervention.
Changes in infants' dermatitis quality of life (IDQOL) index.
Changes in infants' dermatitis quality of life (IDQOL) index were assessed by questionnaire before and 1-, 2- and 3-month intervention. The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.
Time frame: Before and 1-, 2- and 3-month intervention.
Changes in dermatitis family impact (DFI) scores.
Changes in dermatitis family impact (DFI) scores were assessed by questionnaire before and 1-, 2- and 3-months intervention. The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.
Time frame: Before and 1-, 2- and 3-month intervention.
Changes in subjects' frequency of medicine use from questionnaires.
Changes in subjects' frequency of medicine use were assessed from questionnaire before and 1-, 2- and 3-months intervention. When subjects returned to the clinic, the average daily medicine use over the past month is asked by a professional physician.
Time frame: Before and 1-, 2- and 3-month intervention.
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