Cow's Milk Allergy (CMA): Evaluation of Tolerance, Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Hypoallergenicity of the formula
研究概览
简要总结
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.
This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital.
If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.
详细描述
Briefly, on two separate days, the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision, and appearance of allergic symptoms will be witnessed and recorded if any. The week after, and more particularly the 72 hours after each food challenge day, child's parents will be instructed to report to the investigator any delayed reaction that may occur. In case the TEHCF induces an allergic reaction, the child's participation will be ended. Otherwise, the child will enter the second study part, lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF.
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)
盲法说明
Masking only applies to the 1st part of the study : during this part all parties (participant, care provide, investigator and outcomes assessor) will be blinded.
The 2nd study part is open-label , there is no masking during this phase
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 1 and 24 months old
- •having a CMA proven in the last 3 months prior to inclusion
- •free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet)
- •whose parent(s)/legal guardian(s) signed the informed consent form.
排除标准
- •Children mainly (>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding
- •Children with a mean formula intake lower than 250 ml/day
- •Children with past anaphylactic reaction(s)
- •Children with chronic (non acute) FPIES
- •- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject,
- •Children already participating in another clinical trial
结局指标
主要结局
Hypoallergenicity of the formula
时间窗: 7 days
the percentage of children tolerating the formula during the double blind placebo controlled food challenge
次要结局
- Cow's Milk Related Symptom Score (CoMiSS™)(At each visit : day7, day 30, day 60, day 90 and day 120)
- Sleep characteristics(At each visit : day7, day 30, day 60, day 90 and day 120)
- Weight(At each monthly visit day 30, day 60, day 90 and day 120)
- Height(At each monthly visit day 30, day 60, day 90 and day 120)
- BMI(At each monthly visit day 30, day 60, day 90 and day 120)
- Compliance(At each visit : day7, day 30, day 60, day 90 and day 120)
- Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index(At each visit : day7, day 30, day 60, day 90 and day 120)
- Gastrointestinal CMA symptoms(At each visit : day7, day 30, day 60, day 90 and day 120)
- Cutaneous CMA symptoms(At each visit : day7, day 30, day 60, day 90 and day 120)
- Head circumference(At each monthly visit day 30, day 60, day 90 and day 120)
- Adverse event(During the whole study duration)
- Parents' satisfaction(At each visit : day7, day 30, day 60, day 90 and day 120)
- Investigator's satisfaction(At each visit : day7, day 30, day 60, day 90 and day 120)
- Digestive tolerance(At each visit : day7, day 30, day 60, day 90 and day 120)