NCT05318300进行中（未招募）不适用
Assessment of the Effect of Cow's Milk Protein-based Formulas for Infants in the Management of Moderate to Severe aTOPic Dermatitis in Infants Aged Less Than 18 Months
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- EASI (Eczema Area Severity Index) score after 90 days.
研究概览
简要总结
The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.
详细描述
The study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. During this period of time, all infant include in the study will be fed with the study formula.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged below 18 month
- •Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0
- •Whose parents gave their informed consent
排除标准
- •systemic corticotherapy
- •antihistamine
- •use of dermocorticoide and/or antibiotics within 15 days
- •symptoms of cutaneous infection
- •Past anaphylactic shock
- •cow's milk, soya or fish allergy
- •Exclusive or predominant breast feediing (more than one feeding/day)
- •Consumption of less than 500 ml per day
- •Participation to another trial.
研究组 & 干预措施
Tested formula LP-2018
Experimental
infant formula containing fibers
干预措施: tested formula with fiber (Dietary Supplement)
Placebo formula CT-2018
Placebo Comparator
infant formula without fibers
干预措施: Control (Dietary Supplement)
结局指标
主要结局
EASI (Eczema Area Severity Index) score after 90 days.
时间窗: 90 days
evolution of the EASI score between day 0 to day 90. The score range is between 0 (no eczema) and 72 (highest score of eczema)
次要结局
- EASI (Eczema Area Severity Index) score after 180 days.(180 days)
- Skin dryness(180 days)
- PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution(180 days)
- Itching(180 days)
- Quality of sleep (assessed by VAS)(180 days)
- Use of topical dermocorticoids(180 days)
- Length/Height(180 days)
- Sleep time(180 days)
- IDQoL (Infant's Dermatitis Quality of Life)(90 days)
- EASI (Eczema Area Severity Index) score after 30 days.(30 days)
- EASI (Eczema Area Severity Index) score after 60 days.(60 days)
- Satisfaction of the investigator(Day 180)
- Weight(180 days)
- Atopic dermatitis flare(180 days)
- Regurgitations(Day 180)
- Stool's frequency(Day 180)
- Stool's consistency(Day 180)
- Gas, bloating(Day 180)
- Satisfaction of the parents(Day 180)
- Weight(90 days)
- Length/Height(30 days)
- PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution(60 days)
- PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution(30 days)
- PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution(90 days)
- Skin dryness(30 days)
- Skin dryness(60 days)
- Skin dryness(90 days)
- Itching(30 days)
- Itching(60 days)
- Itching(90 days)
- Quality of sleep (assessed by VAS)(30 days)
- Quality of sleep (assessed by VAS)(60 days)
- Length/Height(60 days)
- Quality of sleep (assessed by VAS)(90 days)
- Sleep time(30 days)
- Sleep time(60 days)
- Sleep time(90 days)
- Use of topical dermocorticoids(30 days)
- Use of topical dermocorticoids(60 days)
- Use of topical dermocorticoids(90 days)
- Atopic dermatitis flare(30 days)
- Atopic dermatitis flare(60 days)
- Atopic dermatitis flare(90 days)
- Weight(30 days)
- Weight(60 days)
- Length/Height(90 days)
- Regurgitations(Day 30)
- Regurgitations(Day 60)
- Regurgitations(Day 90)
- Stool's frequency(Day 30)
- Stool's frequency(Day 60)
- Stool's frequency(Day 90)
- Stool's consistency(Day 30)
- Stool's consistency(Day 60)
- Stool's consistency(Day 90)
- Gas, bloating(Day 30)
- Gas, bloating(Day 60)
- Gas, bloating(Day 90)
- Satisfaction of the parents(Day 30)
- Satisfaction of the parents(Day 60)
- Satisfaction of the parents(Day 90)
- Satisfaction of the investigator(Day 30)
- Satisfaction of the investigator(Day 60)
- Satisfaction of the investigator(Day 90)
研究者
研究点 (3)
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