To Evaluate the Acceptability (including Gastrointestinal Tolerance and Compliance) of an Adult Peptide 1.3 Kcal/ml Tube-feed Formula Containing Partially Hydrolysed Guar Gum (PHGG) Fibre.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Assess tolerance via patient diaries
研究概览
简要总结
Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide formula. 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 an adult enteral peptide formula containing Partially Hydrolysed Guar Gum (PHGG) fibre in 15 patients. This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a fourteen-day period. Data will be collected using patient diaries to asses changes in GI tolerance and tube feed intake.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enterally fed adults feeding taking ≥60% of nutritional requirements from enteral nutrition
- •Patients with documented evidence of feeding intolerance or GI symptoms during enteral feeding, and who in the clinical judgement of the supervising dietitian may benefit from a peptide formula with fibre.
- •Aged 18 years and above.
- •Willingly given, written, informed consent from patient
排除标准
- •Inability to comply with the study protocol, in the opinion of the investigator
- •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
Assess tolerance via patient diaries
时间窗: 14 days
Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating
Daily formula intake
时间窗: 14 days
mL
次要结局
未报告次要终点