Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in eczema area and severity index (EASI) scores.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects were between 3 months and 3 years old.
- •For patients diagnosed with atopic dermatitis by a professional physician and the EASI score is greater than 5, the type and frequency of drugs used during the experiment should be recorded.
- •The subject's parents agree to join the trial and sign the informed consent form.
排除标准
- •The patient who has a history of allergic reactions, or the use of other highly sensitive or contraindicated drugs (allergy to antibiotics or antipyretics).
- •The patient who has taken oral immunosuppressants and systemic steroids within the past 2 weeks.
- •The patient who has consumed probiotic-related products (including drops, lozenges, capsules, powder or yogurt) within the past 1 month.
- •The patient who has participated in other clinical studies within the past 1 month.
- •The patient who has received immunotherapy within the past 1 year.
- •The patient who suffering from major diseases (with a IC card for severe illness), congenital diseases.
- •The patient who is not suitable to participate in the trial as assessed by the professional physician.
研究组 & 干预措施
Bifidobacterium longum CCFM1029
干预措施: Bifidobacterium longum CCFM1029 (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in eczema area and severity index (EASI) scores.
时间窗: Before and 3-month intervention.
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.
次要结局
- Changes in gut microbiota ratios.(Before and 3 months of intervention.)
- Changes in eczema area and severity index (EASI) scores.(After 1 month and 2 months of intervention.)
- Changes in dermatitis family impact (DFI) scores.(Before and 1-, 2- and 3-month intervention.)
- Changes in infants' dermatitis quality of life (IDQOL) index.(Before and 1-, 2- and 3-month intervention.)
- Changes in subjects' frequency of medicine use from questionnaires.(Before and 1-, 2- and 3-month intervention.)
研究者
Hsieh-Hsun Ho
R&D Director
Glac Biotech Co., Ltd