Acceptability (including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula with Food-derived Ingredients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Daily formula intake
研究概览
简要总结
Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.
详细描述
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.
Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:
- Gastrointestinal tolerance
- Compliance with prescribed feed volume
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
- •Children 15 years and over
- •Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian.
- •Patients well-established and stable on enteral feeding.
- •Willingly given, written, informed consent from patient or consultee
- •Willingly given, written assent (if appropriate).
排除标准
- •Inability to comply with the study protocol, in the opinion of the investigator
- •Children under 15 years of age
- •Patients receiving mechanical ventilation, sedation or inotropic support
- •Patients on total parenteral nutrition
- •Known food allergies to any ingredients (see ingredients list) or galactosaemia
- •Patients with significant renal or hepatic impairment
- •Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.
- •Participation in another interventional study within 2 weeks of this study.
- •Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.
- •Patients with known or suspected ileus or mechanical bowel obstruction
结局指标
主要结局
Daily formula intake
时间窗: 14 days
mL per day
Daily patient diaries
时间窗: 14 days
Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change
次要结局
未报告次要终点