CTRI/2014/07/004717已完成3 期
A study of an oral nutrition supplement (ONS) in children
Abbott Nutrition International India0 个研究点目标入组 256 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Is an age of 24-72 months (inclusive)(both gender)
- •2.Identified as having current acute upper respiratory tract infection
- •3.Has a weight-for-age between 3rd â?? 15th percentile according to WHO Growth Charts
- •4.Indentified as a picky eater
- •5.Is able to consume foods and beverages orally
- •6.Is willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period
排除标准
- •1.Has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product.
- •2.Has a current illness requiring hospitalization.
- •3.Has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study
- •4.Is currently taking medication that could affect absorption/metabolism of study product or weight of the child. Exception: Topical/ocular steroids will be permitted during the study
- •5.Is diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma. (as per history and documentation in the medical records).
- •6.has active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history and documentation in the medical records)
- •7.Has a history of diabetes mellitus (as per history and documentation in the medical records)
- •8.has been on antibiotic therapy within the last two weeks before start of the study (before study Day 1)
- •9.Has dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product. (as per history and documentation in the medical records)
- •10.Has a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator.
研究者
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