A Single Arm Intervention Study to Assess the Acceptability, Tolerance and Ease of Use of Wilbo's Blends+ (Commercial Enteral Feed Based on Real Food) When Used as Part of a Dietitian Prescribed Enteral Feeding Plan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability with regard to gastrointestinal tolerance
研究概览
简要总结
The goal of this observational study is to learn if tube-fed children and young people (age 3-15 years) find Wilbo's Blends+ (a new nutritionally complete enteral formula containing real food ingredients) acceptable, tolerable and easy to use. The main question it aims to answer is:
Is Wilbo's Blends+ acceptable when included in the feeding plan of tube-fed children and young people (age 3-15 years)
Participants will:
Take Wilbo's Blend+ for a 7 day period as part of their feeding plan Complete questionnaires about their gastrointestinal symptoms
详细描述
THEORETICAL FRAMEWORK The study design follows the UK Advisory Committee on Borderline Substances (ACBS) criteria to support submission for prescription usage in the National Health Service (NHS).
RESEARCH QUESTION / AIM(S) Is a commercially prepared nutritionally complete enteral formula made with real food ingredients accepted, tolerated and complied with instead of a patient's usual enteral formula?
Objectives
Primary:
To test the acceptability of Wilbo's Blends+ with regards to GI tolerance and compliance, following UK ACBS criteria to support submission for prescription usage in the NHS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and young people (age 3-15) who are assessed by a Doctor or Dietitian as requiring enteral tube feeding via gastrostomy.
- •Children and young people able to receive a minimum of 30% of their daily intake from the study product for at least 7 consecutive days.
- •Participant is capable of communication/filling in the questionnaires or having a parent/carer who can answer the questions by close observation of the participant reactions. If there are any communication issues the research dietitian/nurse should support. Written, informed consent from the parent/carer/guardian and assent from the participant obtained.
排除标准
- •<3 years old
- •>15 years old
- •Total Parenteral Nutrition
- •Post pyloric enteral feeding
- •Enteral tube feeding via Nasogastric tube
- •Patients with severe renal, oncology, metabolic, IBD or hepatic conditions who are considered clinically unstable
- •Known food allergies or intolerances to any ingredient in the product
- •Requirement of a fibre free feed (e.g. IBD)
- •Children who had an inability to comply with the study protocol, in the opinion of the investigator
- •Children who have been involved in another interventional study within 2 weeks of this study.
- •Children with recent changes (within 1 week) in medication used to manage gastrointestinal symptoms
研究组 & 干预措施
• Children and young people (age 3-15) who are assessed by a Doctor or Dietitian as requiring entera
A new feeding plan will be developed by the study dietitians. Participants will be transitioned from their current enteral feeding plan to incorporate Wilbo's Blends+. In this new plan Wilbo's Blends+ can provide up to 100% but not lower than 30% of their total daily calorie requirements depending on participant's individual clinical needs, as assessed by the study dietitian.
干预措施: Wilbo's Blends+ (Dietary Supplement)
结局指标
主要结局
Acceptability with regard to gastrointestinal tolerance
时间窗: Days 1-7
Parents/carers will be asked to record gastrointestinal patterns and any symptoms (Diarrhoea, constipation, bloating, nausea, vomiting, burping, flatulence, regurgitation, abdominal pain or discomfort) using a questionnaire.
次要结局
- Ease of use(Day 8)
- To test where possible palatability of the Wilbo's Blends+ product.(Day 8)
- Health Care Team perceptions of Wilbo's Blends+.(September 25-March 26)