NCT04318509已完成不适用
Market Research - Acceptability Study for a New PKU Glycomacropeptide Based Protein Substitute (Dr Schär- Mevalia Amino Acids) Mevalia PKU GMPower - Vanilla
Dr. Schär AG / SPA4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年2月4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
- 8
- 试验地点
- 4
- 主要终点
- Gastrointestinal tolerance
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 protein substitute.
- •Subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days.
- •Patients aged 3 years of age to adulthood.
- •Written informed consent obtained from participant or parental caregiver (as appropriate).
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
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.
Product compliance
时间窗: 7 days
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Product palatability
时间窗: 7 days
Questionnaire data captured to evaluate taste
Product acceptability
时间窗: 7 days
Brief tick-box questionnaire on overall liking and acceptability of product
次要结局
未报告次要终点
研究者
研究点 (4)
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