NCT05025267已完成不适用
Prospective Study of Ability to Meet Nutritional Needs with a Peptide-based, High Protein Enteral Formula
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Calorie nutritional goals
研究概览
简要总结
This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.
详细描述
This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with established enteral access
- •Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
- •Signed informed consent
排除标准
- •Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- •Any condition that would contraindicate use of the study product
- •Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment
- •Judged to be at risk for poor compliance to the study protocol
- •Participating in a conflicting clinical trial
结局指标
主要结局
Calorie nutritional goals
时间窗: 14 days
Daily percentage of calorie nutritional goals met
次要结局
- Daily reports of gastrointestinal intolerance(14 days)
- Adverse events(14 days)
- Protein nutritional goals(14 days)
研究者
研究点 (2)
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