NCT04516213已完成不适用
An Open-label, Single-arm Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years.
Société des Produits Nestlé (SPN)10 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年2月28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
- 24
- 试验地点
- 10
- 主要终点
- GI Intolerance
研究概览
简要总结
This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years over a 7 day period.
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 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent from subject and/or subject's parents or legally authorized representatives (LAR).
- •Male or female, 12 to 48 months of age, inclusive.
- •Subjects requiring enteral feeding for > 7 days (in hospital, long-term care facility or at home).
- •Subjects receiving enteral tube-feeding (nasogastric feeding tube or percutaneous endoscopic gastrostomy [PEG] tube) to provide 90% or more of their nutritional needs at the time of study entry.
- •Subject is clinically stable (i.e. absence of any significant gastrointestinal symptoms during the past 7 days), in the opinion of the investigator.
排除标准
- •Subjects receiving partial or total parenteral nutrition (e.g. for short bowel syndrome and other causes of intestinal failure).
- •Subjects with ongoing or intermittent significant gastrointestinal symptoms during the 7 days before enrollment.
- •Oncology patients recovering from chemotherapy or radiotherapy for hematological malignancies or solid tumors (last treatment within 3 months of enrollment).
- •Congenital immunodeficiency syndromes (SCID etc).
- •Cystic fibrosis and other causes of fat malabsorption (lymphatic malformations/lymphangiectasis).
- •Subjects with any clinically significant condition (e.g. severe malnutrition, congenital heart disease, etc) that, in the investigator's opinion, would preclude inclusion in the study.
- •Subjects at risk for poor compliance to the study protocol in the investigator's opinion.
- •Currently participating in another conflicting trial or participated in an investigational trial within 30 days of enrollment.
- •Known hypersensitivity to PHGG or to any other ingredients in the investigational product.
结局指标
主要结局
GI Intolerance
时间窗: 7 Days
Occurrence of gastrointestinal intolerance (yes/no)
次要结局
- Adverse Events(7 Days)
- Change in Weight(7 Days)
- Energy Requirements Met(7 Days)
研究者
研究点 (10)
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