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临床试验/NCT01422980
NCT01422980已完成不适用

Effect of Consumption of Dairy Product on Upper Gastric Discomfort

Danone Research2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2010年11月1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
236
试验地点
2
主要终点
Change in gastro-oesophageal symptoms as assessed by RDQ questionnaire

研究概览

简要总结

The purpose of this study is to determine whether the consumption of test dairy products is effective in reducing upper gastric discomfort after 2 weeks of product consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female
  • 21 - 60 years old
  • Experiencing upper gastric discomfort

排除标准

  • Participants with alarm symptoms (dysphagia, bleeding, involuntary weight loss clinically significant >10% of it habitual weight during the last 6 months).
  • Participants with diagnosed severe organic esophageal medical history (endoscopic eosophagitis A, B, C or D of Los Angeles classification, peptic stenosis, Barrett oesophagus, huge hiatus hernia or para-esophageal) gastric or duodenal ulcer or high digestive haemorrhage clinical history.

结局指标

主要结局

Change in gastro-oesophageal symptoms as assessed by RDQ questionnaire

时间窗: Two timepoints are considered in the assessment of the change outcome measures: from Baseline (before product consumption) to Endpoint (i.e. final evaluation visit after 2 weeks of product consumption)

次要结局

未报告次要终点

研究者

发起方
Danone Research
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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