NCT01814202已完成不适用
A Double-blind, Randomized, Placebo-controlled Clinical Trial (Pilot Phase) to Evaluate the Efficacy of a Medical Nutrition Product, PTM202, in Children With Acute Diarrhea
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- diarrhea duration
研究概览
简要总结
The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females between 6 months and 5 years of age
- •acute diarrhea (<48 hours) without interfering co-morbidities
- •guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on Day 7 for a final evaluation
- •Guardian is willing and able to report to the Investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase.
- •Written informed consent must be obtained prior to admission to this study.
- •The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.
排除标准
- •Suspected or confirmed cholera
- •Suspected dysentery
- •Symptom duration >48 hours at screening
- •Vomiting severity that is like to make administration and retention of test article impossible
- •Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6).
- •Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.
- •History of hypersensitivity or allergy to milk or egg
研究组 & 干预措施
PTM202
Experimental
PTM202 is a medical nutrition product
干预措施: PTM202 (Other)
Placebo
Placebo Comparator
The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor
干预措施: Placebo (Other)
结局指标
主要结局
diarrhea duration
时间窗: 7 days
次要结局
- food intake(7 days)
- stool frequency(7 days)
- stool consistency(7 days)
研究者
研究点 (1)
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