NCT01727115已完成不适用
Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance
Société des Produits Nestlé (SPN)28 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2008年4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
- 116
- 试验地点
- 28
- 主要终点
- The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.
研究概览
简要总结
The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants from few days of life until 6 months of age
- •Birth weight : between 2.500g and 4.500g
- •Full term: gestational age between 37 and 42 weeks
- •Singleton birth
- •Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI)
- •Having obtained the Informed Consent by the Parents or the legal guardian
排除标准
- •Exclusive breastfeeding at time of enrolment
- •Having been treated before enrolment with an extensively hydrolysed formula
- •Disease impairing a normal gut transit (like pyloric stenosis)
- •Intolerance to lactose (if already known)
- •Receiving an antibiotic treatment at the time of enrolment
- •Severe or chronic diarrhea
- •Failure to thrive
- •Neurologic diseases
- •Receiving a medical treatment which could interfere with the protocol or after a surgical intervention
- •Infants whose parents / caregivers who cannot be expected to comply with treatment
- •Currently participating or having participated in another interventional clinical trial
结局指标
主要结局
The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.
时间窗: 4 weeks
regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms
次要结局
- To assess whether the 2 groups have comparable changes in weight, length and head circumference(1 year)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
2 期
Formoterol Via pMDI HFA-134a Propellant or DPI in Partially Reversible Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary DiseaseNCT00742248Chiesi Farmaceutici S.p.A.54
已完成
3 期
A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)HypolactasiaNCT01145339Eurofarma Laboratorios S.A.140
已完成
1 期
Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different FormulationsHealthyNCT02070796UCB Pharma SA50
尚未招募
不适用
To compare the efficacy of two forms of parenteral iron preparations in the management of post partum anemiaCTRI/2019/02/017699Dr Rimpi Singla
已完成
不适用
Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®Vaginal DiseaseNCT04245293Italfarmaco50