NCT03844373已完成不适用
Tolerance and Acceptability Evaluation of STOCKHOLM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- GI Tolerance
研究概览
简要总结
Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.
详细描述
To evaluate tolerance and acceptability of 'STOCKHOLM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
To obtain data to support an ACBS submissions for 'STOCKHOLM' (to allow for prescription in the community at NHS expense).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are able to communicate their views regarding acceptability.
- •Patients established on an oral nutritional supplement, being prescribed ONS providing approximately 300 kcal/day
- •Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- •Informed consent obtained.
排除标准
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- •Patients requiring a milk free diet
- •Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
- •Patients with significant renal or hepatic impairment
- •Patients with dysphagia requiring stage 1,2 or 3 thickened fluids
- •Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
结局指标
主要结局
GI Tolerance
时间窗: 9 Days
To assess gastro-intestinal tolerance of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements as assessed on the Bristol stool form scale, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
次要结局
- Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire(9 days)
- Compliance with Prescription of STOCKHOLM(9 days)
研究者
研究点 (2)
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