Tolerance and Acceptability of AYMES ROME
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- GI side effects when using AYMES Rome
研究概览
简要总结
- To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
- To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).
详细描述
To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.
To obtain data to support an ACBS submissions for AYMES ROME (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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
- •Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/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 swallowing impairment requiring thickened fluids
- •Patients with inflammatory bowel disease or previous bowel resection.
研究组 & 干预措施
intervention
Patients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES Rome for a period of 9 days
干预措施: AYMES ROME (Dietary Supplement)
结局指标
主要结局
GI side effects when using AYMES Rome
时间窗: 9 days
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES Rome as assessed by presence / absence of side effect compared to baseline period
次要结局
- Change to bodyweight of subjects when using AYMES Rome(9 days)
- Compliance with prescription of AYMES Rome(9 days)
- Bowel habits of subjects when using AYMES Rome - frequency(9 days)
- Bowel habits of subjects when using AYMES Rome - stool consistency(9 days)