Tolerance and Acceptability Evaluation AYMES Cardiff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Gastro-Intestinal Tolerance when consuming AYMES CARDIFF
研究概览
简要总结
To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
详细描述
To evaluate tolerance and acceptability of 'CARDIFF' 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 'CARDIFF' (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
- •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 ≥ 30 days.
- •Patient is able and willing to provide written informed consent.
排除标准
- •Patients with medical or dietary contraindication to any feed ingredients.
- •Patients requiring sole enteral tube feeding or parenteral nutrition.
- •Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
- •Patients with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
- •Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
- •Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
- •Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.
结局指标
主要结局
Gastro-Intestinal Tolerance when consuming AYMES CARDIFF
时间窗: 30 days
To assess gastro-intestinal tolerance of 'CARDIFF' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary.
次要结局
- Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire(30 days)
- Compliance(30 days)