NCT02711163已完成3 期
Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
研究概览
简要总结
The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
- •successfully fed an eviction diet for at least 2 weeks
- •Main Non-inclusion Criteria:
- •fed with an extensively hydrolyzed formula with no improvement of the symptoms,
- •who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
- •fed a vegetable based formula
- •fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
- •who had an anaphylactic reaction in the past
排除标准
- 未提供
研究组 & 干预措施
Extensively hydrolyzed formula
Experimental
Feeding extensively hydrolyzed formula
干预措施: Extensively Hydrolyzed formula (Dietary Supplement)
Amino acid formula
Placebo Comparator
Feeding amino acid formula
干预措施: Amino acid formula (Dietary Supplement)
结局指标
主要结局
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
时间窗: 7 days
次要结局
- Regurgitation assessed through Vandenplas score(7, 45 and 90 days)
- Abdominal pain (severity on a 4 level scale)(7, 45 and 90 days)
- Weight expressed in z scores according to the WHO Child Growth Standards(45 and 90 days)
- Stool consistency assessed through Bristol Stools Form Scale(7, 45 and 90 days)
- Duration of crying over 24h(7, 45 and 90 days)
- Urticaria (presence/absence)(7, 45 and 90 days)
- Eczema assessed through SCORAD(7, 45 and 90 days)
- Vomiting (weekly frequency)(7, 45 and 90 days)
- Bloating and gas (severity on a 4 level scale)(7, 45 and 90 days)
- Sleeping time over 24h(7, 45 and 90 days)
- Stool frequency over 72h(7, 45 and 90 days)
- Blood in stools (presence/absence)(7, 45 and 90 days)
- Respiratory symptoms (severity on a 4 level scale)(7, 45 and 90 days)
- Height expressed in z scores according to the WHO Child Growth Standards(45 and 90 days)
- BMI expressed in z scores according to the WHO Child Growth Standards(45 and 90 days)
- Head circumference expressed in z scores according to the WHO Child Growth Standards(45 and 90 days)
- Number of patients with treatment emergent Adverse Events(7, 45 and 90 days)
研究者
研究点 (1)
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