NCT02103972已完成不适用
Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis
Société des Produits Nestlé (SPN)12 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 12
- 主要终点
- Change from Baseline SCORAD Score at 16 weeks of treatment
研究概览
简要总结
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.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group).
- •With mild to severe atopic symptoms: SCORAD ≥ 20 (at V0b).
- •Having obtained his/her (or his/her legal representative's) written Informed Consent.
排除标准
- •SCORAD inferior to 20 (SCORAD less than 20 at V0b). A SCORAD less than 20 at V0c is not an exclusion criteria.
- •Infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine A).
- •Infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. Of note: Infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (V0b), can continue to use this probiotic during the intervention period and will not be excluded. Recent introduction of probiotics, within a month before the planned start of the study (V0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and V0b).
- •Infants having other inflammatory skin diseases (urticaria, psoriasis).
- •Infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency).
- •Infants whose parents/caregivers cannot be expected to comply with the study procedures.
- •Infants currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
- •Infants using topical calcineurin inhibitors (e.g. tacrolimus and pimecrolimus (ELIDEL®)) during the study.
- •Infants who have undergone in the month before the start of the study (V0b), are currently undergoing or are anticipated to undergo ultraviolet light therapy or wet dressing or any other topical treatment of their eczema other than the one provided in the study. Lotion and skin moisturizer are allowed but need to be monitored for frequency and area.
- •The investigator and clinician will assess if the child has to be excluded based on the patient's medical condition and taken into account the values of the safety parameters tested. Therefore, no cut-off values, or normal ranges for the different safety parameters are exclusion criteria. It will be the responsibility of the investigator and clinician, based on their medical judgement, to decide if it is safe or not to include an infant into the study.
结局指标
主要结局
Change from Baseline SCORAD Score at 16 weeks of treatment
时间窗: between 0 and 16 weeks of treatment
SCORAD documented during the longitudinal observational period of 16 weeks after the subject has enrolled
次要结局
- Score A, B and C of the SCORAD(0, 4, 10 and 16 weeks of treatment)
- Transepidermal water loss(0, 4, 10 and 16 weeks)
- Topical treatment used(during the 16 weeks of treatment)
- "Objective" SCORAD, which is composed of part A and B of the SCORAD (measured at V0, V1, V2 and V3)(0, 4, 10 and 16 weeks)
- Number and duration of atopic dermatitis episodes(during the 16 weeks intervention period)
- total and specific IgE(0 and 16 weeks)
- Quality of Life(0, 4, 10, 16 weeks and 1 and 4 years later)
- assess the effect of the product on the safety parameters(0 and 16 weeks)
研究者
研究点 (12)
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