NCT05026476已完成不适用
Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance) of a Thickener
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年8月16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
- 21
- 试验地点
- 1
- 主要终点
- Gastrointestinal tolerance
研究概览
简要总结
This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia
详细描述
To evaluate the gastrointestinal tolerance and compliance of a thickener for 7 days for the submission to the Advisory Committee for Borderline Substances (ACBS).
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
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I. Infants and children aged 6 months and over who require a thickener for reflux, GORD, dysphagia II. Infants and children already on a thickener for the management of reflux, GORD and dysphagia III. Parents to avoid introducing new weaning/ new foods (for the older infants) whilst on the thickener for 1 week when measuring GI tolerance and thickener intake IV. Willingly given, written, informed consent from patient or parent/guardian
排除标准
- •I. Inability to comply with the study protocol, in the opinion of the investigator.
- •II. Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Allergy to milk (thickener is made in a factory that handles milk) IV. Children under the age of 6 months of age V. Emergencies VI. Participation in another interventional study
结局指标
主要结局
Gastrointestinal tolerance
时间窗: 7 days
Measure using daily diary
次要结局
- Participant compliance(7 days)
研究者
研究点 (1)
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