Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 22
- 主要终点
- Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula)
研究概览
简要总结
The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Days 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable)
- •Child gestational age ≥ 37 completed weeks
- •Child aged ≥ 60 days and less than 36 months at enrollment
- •Documented IgE-mediated CMPA no more than 6 months prior to enrollment
- •Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
- •Child's parent(s) and LAR (if applicable) is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol
排除标准
- •Child is exclusively breastfed
- •Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
- •Congenital heart disease or treatment by B-blockers
- •Major gastrointestinal disease / abnormalities (other than CMPA)
- •Known or suspected soy allergy
- •Glucose-galactose malabsorption
- •Immunodeficiency
- •Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment
- •Persistent wheeze or chronic respiratory disease
- •Severe uncontrolled eczema or urticaria
- •Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas
- •Child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the child inappropriate for entry into the study
- •Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
- •Child's parents have not reached legal age of majority (18 years).
研究组 & 干预措施
Experimental formula-Control formula
Blinded cross-over oral food challenge sequence starting by Experimental formula followed by Control.
Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.
干预措施: Experimental formula (Other)
Experimental formula-Control formula
Blinded cross-over oral food challenge sequence starting by Experimental formula followed by Control.
Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.
干预措施: Control formula (Other)
Control formula-Experimental formula
Blinded cross-over oral food challenge sequence starting by Control followed by Experimental formula.
Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.
干预措施: Experimental formula (Other)
Control formula-Experimental formula
Blinded cross-over oral food challenge sequence starting by Control followed by Experimental formula.
Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.
干预措施: Control formula (Other)
结局指标
主要结局
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula)
时间窗: during test day
by measuring the proportion of participants who "passed" the food challenge test, meaning who consumed all doses and exhibited no allergic reactions to any of the doses of the experimental formula.
次要结局
- Gastrointestinal tolerance of experimental formula during at home consumption period(during 7 days)
- Safety of experimental formula during the at-home consumption(during 7 days)