NCT02538250已完成4 期
Acceptability Study on Nutricomp Drink Plus in Adult Patients
B. Braun Medical UK Ltd.2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)
研究概览
简要总结
Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •≥ 18 years of age
- •Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days
- •Patient is able and willing to provide written informed consent
排除标准
- •Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients
- •Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)
- •Patients who express general dislike to two or more of the four flavours
- •Severely impaired gastrointestinal function or complete failure
- •Severe metabolic or circulatory disorders
- •Acute disease
- •Unstable vital functions
- •Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy
- •Simultaneous participation in another interventional study
- •Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
- •Pregnancy
- •Emergencies
结局指标
主要结局
Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)
时间窗: 7 days
Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary
次要结局
- Occurrence of further adverse effects(7 days)
- Evaluation of compliance.(7 days)
- Evaluation of palatability by questionnaire(1 day)
研究者
研究点 (2)
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