A Multicenter Clinical Trial To Assess The Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children.
试验速览
- 阶段
- 不适用
- 入组人数
- 376
- 试验地点
- 6
- 主要终点
- atopic dermatitis prevalence at M12
研究概览
简要总结
Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). Recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. So far, most human intervention studies have mainly focused on improving postnatal infant colonization. Our study will test the hypothesis that a maternal antenatal prebiotics (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk children.
详细描述
Study design :
Inclusion visit at 20 weeks of gestation :
- randomization
- start of supplementation (GOS/inulin or placebo)
Phone call at 24 weeks of gestation :
- checking tolerance
- checking observance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with an eutocic pregnancy before 20 weeks of gestation
- •women with personal history of atopy diagnosed by a healthcare Professional
- •Women accepting a complete avoidance of dietary supplements containing prebiotics or probiotics during study supplementation
- •women accepting dermato-pediatric follow-up during the first year of life of the new-born (Phone calls at 24 weeks of gestation and 6 months of child and a consultation at 12 months of age)
- •non Tobacco user women
- •women over 18 years
- •women without history of severe gestational diabetes
排除标准
- •women not giving up on intake of dietary supplements containing prebiotics or probiotics during study supplementation
- •women refusing dermato-pediatric follow-up during the first year of the newborn
- •ongoing allergy and/or intolerance to cow's milk proteins
- •term >21 weeks of gestation
结局指标
主要结局
atopic dermatitis prevalence at M12
时间窗: at 12 months of age
prevalence will be evaluated according to UK party working group criteria
次要结局
- food allergies prevalence at M12(at 12 months of age)
- sensitization with the major allergens(at 12 months of age)
- Quality of life of the child and his/her family(at 12 months of age)
- atopic dermatitis prevalence at M6(at 6 months of age)
- Tolerance of the prebiotics in mothers(from inclusion to delivery)
- assessment of the Transepidermal Waterlos(at J1 and at 12 months of age)
- atopic dermatitis severity(at 12 months of age)