NCT04309331已完成不适用
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute (Dr Schär Medical Nutrition - Mevalia Amino Acids) Mevalia PKU Motion 10 - Tropical or Red Fruits Mevalia PKU Motion 20 - Tropical or Red Fruits
Dr. Schär AG / SPA2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年7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
- 12
- 试验地点
- 2
- 主要终点
- Product palatability
研究概览
简要总结
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute
- •Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days
- •Patients aged 3 years of age to adulthood
- •Written informed consent obtained from parental caregiver
排除标准
- •Presence of serious concurrent illness
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- •Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
- •Patients less than 3 years of age.
结局指标
主要结局
Product palatability
时间窗: 7 days
Questionnaire data captured to evaluate taste
Product compliance
时间窗: 7 days
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Product acceptability
时间窗: 7 days
Brief tick-box questionnaire on overall liking and acceptability of product
Gastrointestinal tolerance
时间窗: 7 days
Questionnaire detailing any GI symptoms, severity and change from usual • The collection of daily data about the gastro-intestinal tolerance of the protein substitute.
次要结局
未报告次要终点
研究者
研究点 (2)
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