ISRCTN12387189已完成未知
PKU GOLIKE PLUS 3-16 – Acceptability and Tolerance Market Research Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 13
研究概览
简要总结
2020 results in https://pubmed.ncbi.nlm.nih.gov/32899129/ (added 20/01/2021)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Male and female patients with a diagnosis of phenylketonuria, aged 3-16 years
- •2. Subjects who are already taking a protein substitute for PKU and are willing to try the study product for 7 days
- •3. Written informed consent obtained from parental caregiver
排除标准
- •1. Presence of serious concurrent illness
- •2. Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- •3. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- •4. Any children having taken antibiotics over the previous 2 weeks leading up to the study
- •5. Children aged less than 3 years
研究者
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