NCT06209593招募中不适用
Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Plant Based High Energy Adult Enteral Formula
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年1月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance
研究概览
简要总结
This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.
详细描述
Enterally fed adults who are assessed by the Health Care Professional/dietitian as requiring an adult plant- based high-energy, enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the UK Advisory Committee on Borderline Substances (ACBS) for product registration
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 16 years and over and adults requiring a plant- based enteral tube feed (taking 50% or more of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
- •Patients well-established and stable on current polymeric enteral tube feed.
- •Willingly given, written, informed consent from patient
排除标准
- •Inability to comply with the study protocol, in the opinion of the investigator
- •Under 16 years of age
- •Patients on total parenteral nutrition
- •Known food allergies to any ingredients including patients who have an allergy to milk protein e.g IgE and non- mediated as product contains traces of milk and allergy to peanuts due to the pea protein
- •Patients with significant renal or hepatic impairment
- •Participation in another interventional study within 2 weeks of this study.
- •Patients with known or suspected ileus or mechanical bowel obstruction
结局指标
主要结局
Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance
时间窗: 7 days
Diarrhoea, constipation, reflux, vomiting, wind, boating
次要结局
未报告次要终点
研究者
研究点 (1)
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