Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Paediatric Tube-feed Formula Ingredients Derived From Real Food for Children Over 12 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- Participant compliance
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 pediatric 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; feeding intolerances, developmental disabilities, disease related malnutrition 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 enteral tube feed will be changed to a 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, a nutritionally complete standard enteral tube feed.
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, current oral intake 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
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- Female
- 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
- •Paediatrics aged 1 year above.
- •Patients well established and stable on a standard or peptide enteral formula (no gastrointestinal intolerances on 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
- •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
结局指标
主要结局
Participant compliance
时间窗: Day 7 from baseline
Volume of test product prescribed versus actually taken
Gastrointestinal tolerance
时间窗: Day 7 from baseline
Incidence of gastrointestinal adverse effects. 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.
次要结局
- Body Weight(Day 7 from baseline)