To Evaluate the Acceptability (including Gastrointestinal Tolerance and Compliance) of an Adult Tube-feed Formula with Ingredients Derived from Food.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Daily record via participant diary
研究概览
简要总结
Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) submission for Ireland for product registration.
详细描述
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult tube-feed formula with ingredients derived from food for the dietary management of participants who require a tube feed. .
The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service
Executive (HSE) for Ireland. Participants will be provided with one month supply of 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 volumes
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Require a tube feed (taking >75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
- •Adults and children requiring an adult enteral formula as assessed by the dietitian.
- •Patients well-established and stable on a standard formula or currently on Isosource® Junior Mix.
- •Willingly given, written, informed consent from patient or consultee. For those who lack capacity to provide formal consent for themselves, this may be provided by a personal or consultee in accordance with the Mental Capacity Act.
- •Willingly given, written assent (if appropriate) on behalf of patients under 18.
排除标准
- •Inability to comply with the study protocol, in the opinion of the investigator
- •Known food allergies to any ingredients (see ingredients list)
- •Patients with significant renal or hepatic impairment - Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
- •Participation in another interventional study within 2 weeks of this study.
研究组 & 干预措施
Patients well established on tube feeds will act as their own control
Patients will switch from current to new tube feed.
干预措施: Compleat (Dietary Supplement)
结局指标
主要结局
Daily record via participant diary
时间窗: 7 days
Daily Gastrointestinal diary as questionnaire, increase, decrease or no change
Formula intake diary
时间窗: 28 days
mL per day
次要结局
未报告次要终点