To Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Low Calorie Peptide Based Paediatric Tube-feed Formula; for Children Greater Than 1 Year of Age.
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
- 6
- 主要终点
- Gastrointestinal tolerance
研究概览
简要总结
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae;
The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).
详细描述
Patients well established and stable on a standard or peptide enteral tube feed will be changed to a low calorie paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula.
The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms and weight at the start of the study.
The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.
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
- •Exclusively tube fed
- •Paediatrics aged 1 year above who require a low calorie feed
- •Children with Neurological impairment (NI) who require long term tube feeding
- •Patients established on a standard or peptide Enteral formula (no gastrointestinal intolerances on a current formula)
- •Willingly given, written, informed consent from patient or parent/guardian.
- •Willingly given, written assent (if appropriate).
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
- •Participation in another interventional study within 2 weeks of this study.
结局指标
主要结局
Gastrointestinal tolerance
时间窗: Day 7 from baseline
Incidence of gastrointestinal adverse effects \[ Time Frame: day 7 from baseline \]. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study. nausea, vomiting. burping, flatulence and regurgitation and abdominal discomfort or pain
Participant compliance
时间窗: Day 7 from baseline
Volume of test product prescribed versus actually taken
次要结局
- Body weight(Day 7 from baseline)