NCT04599946进行中（未招募）不适用
Effects of Infant Feeding With Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,132
- 试验地点
- 13
- 主要终点
- Cumulative incidence of atopic dermatitis up to the age of 12 months
研究概览
简要总结
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
详细描述
The study is a randomized, double-blind, parallel-group trial to study the effect of feeding infants goat milk or cow milk formula in the first year of life on the risk of allergy and other health outcomes, including growth, tolerance and quality of life in the first 5 years of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadrupole
入排标准
- 年龄范围
- 0 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having obtained written informed consent (signed and dated) of the child's parent(s)/caregiver(s), indicating that the child's parent(s)/caregiver(s) has/have been informed of all pertinent aspects of the study
- •Born full term (≥37 weeks +0 days and ≤ 41 weeks +6 days of gestation)
- •Age at enrolment < 3 months of age (<90 days)
- •Birth weight ≥2.5 kg and ≤4.5 kg
- •Born from a singleton pregnancy
- •Child's parent(s)/caregiver(s) is/are of legal age of consent
- •The child's parent(s)/caregiver(s) have sufficient local language skills to understand the study information, the informed consent, and to comply with the study procedure
- •The child's parent(s)/caregiver(s) is/are willing and deemed able to fulfil the requirements of the study protocol and procedures
- •Mother has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed
排除标准
- •Diagnosed disorder considered to interfere with nutrition, growth or development of the immune system
- •Participation of the child in any other interventional trial or participation of the mother in any intervention trial with child follow-up
- •Infant has a doctor's diagnosis of atopic dermatitis or a severe widespread skin condition prior to randomization that would make the detection or assessment of atopic dermatitis difficult
- •Infant has consumed an infant formula for more than 4 weeks prior to enrolment
- •Cow milk allergy or intolerance
- •Institutionalized infant
结局指标
主要结局
Cumulative incidence of atopic dermatitis up to the age of 12 months
时间窗: Age 12 months
Cumulative incidence of atopic dermatitis up to the age of 12 months diagnosed by study personnel (defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis)
次要结局
- Gut microbiome profile(at 4, 12 and 60 months of age)
- Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months(Age 12, 24 and 60 months)
- Point incidence of atopic dermatitis(at 4, 6, 12, 24 and 60 months of age)
- Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months(Age 24 and 60 months)
- Cumulative incidence of atopic dermatitis in risk-related subgroups(Age 12, 24 and 60 months of age)
- Incidence of allergic sensitization to food or non-food allergens(Age 12 and 60 months of age)
- Incidence of hay fever, asthma and asthma-related diseases(Age 12, 24 and 60 months)
- Severity of atopic dermatitis(at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age)
- Cumulative use of atopic dermatitis-related medication(Age 12, 24 and 60 months of age)
- Genetic markers: blood markers(at 12 months of age)
- Sleep(at 4, 6 and 12 months of age)
- Child's wellbeing(at 4, 12, 24 and 60 months of age)
- Time to onset of atopic dermatitis(Age 12, 24 and 60 months)
- Incidence of parental reported food allergy(Age 12, 24 and 60 months of age)
- Biochemical markers: blood markers(at 4, 12 and 60 months of age)
- Gastrointestinal symptoms(at 4, 6 and 12 months of age)
- Nutrition(at age 4, 6, 8, 10, 12 and 60 months of age)
- Biochemical and metabolic markers: blood markers(at 4, 12 and 60 months of age)
- Growth parameters(at baseline, 4, 6, 12, 24 and 60 months of age)
研究者
研究点 (13)
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