Acceptability (Including Gastrointestinal Tolerance, Compliance) of a Vegetarian Paediatric Enteral Tube Feed With Food Derived Ingredients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Gastrointestinal tolerance and formula intake
研究概览
简要总结
This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.
详细描述
Acceptability (including gastrointestinal tolerance, compliance of a paediatric vegetarian tube feed with food derived ingredients. Gastrointestinal tolerance will data will be collected using a 4point Likert scale, daily record of tube feed volume 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 1 -15 years requiring more than 50% of energy from tube feeding or to take alongside home-made blended diet as part of their dietary management for disease related malnutrition.
- •Patients well-established and stable on current nutritional support regimen. Willingly given, written, informed consent from patient/caregiver
排除标准
- •No established tube feed.
- •Inability to comply with the study protocol, in the opinion of the investigator.
- •Under 1 years of age
- •Patients on parenteral nutrition
- •Known food allergies, including to any ingredients listed in appendix
- •Participation in another interventional study within 2 weeks of this study.
- •Patients with known or suspected ileus or mechanical bowel obstruction
研究组 & 干预措施
Children will act as their own control for the nutritional product
Gastrointestinal tolerance and daily formula intake over 28 days.
干预措施: paediatric tube feed (Dietary Supplement)
结局指标
主要结局
Gastrointestinal tolerance and formula intake
时间窗: From enrolment to end of study over 28 days
Daily gastrointestinal tolerance measured using a 4 point Likert scale of none, mild, moderate, severe symptoms over days.
Formula volume intake in mL
时间窗: From enrolment to end of study over 28 days
Formula intake measured daily in mLs over 28 days.
次要结局
未报告次要终点