DRKS00027255招募中未知
Development of an allergen containing test-biscuit for special, traditional feeding of babies - Solids-by-kiss
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main0 个研究点目标入组 100 人开始时间: 2022年4月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 Months 至 8 Months（—）
- 性别
- All
入选标准
- •1. Healthy, full-term born infants
- •2. Age 4 – 8 months at Screening
- •3. Positive family history for atopic diseases
- •4. Signed informed consent of parents
- •5. Parents/ caregivers have the mental and linguistic capability to follow the protocol requirements
排除标准
- •1. Previous consumption of hen´s egg, cow´s milk (except infant formula), peanut or hazelnut
- •2. Wheat allergy
- •3. Any other condition (for example severe concurrent disease, infection, comorbidity, e.g. acute trauma, serious oncological disease, serious renal disease, relevant cardiovascular disease, autoimmune diseases) or reason that may interfere with the ability to participate in the study, cause undue risk, or complicate the interpretation of data, in the opinion of the investigator
- •4. Participation in another interventional trial
- •5. Mother/caregiver with food allergy against hen´s egg, cow´s milk, peanut, wheat or hazelnut
- •6. Mother/caregiver who is going to chew solids with (acute) oral infections according to physicians decision
研究者
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