NCT02900196终止不适用
Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders
Danone Research2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2016年9月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Occurrence of AAD
研究概览
简要总结
The purpose of this clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have read and signed the Study Informed Consent Form
- •Subjects positive for Helicobacter pylori infection and symptomatic due to Helicobacter pylori infection
- •Subjects with an indication, as stated by a Gastroenterologist, for the eradication of Helicobacter pylori
排除标准
- •Female subjects with a positive pregnancy test (based on serum test), or planning to become pregnant during the study or breast-feeding women
- •Subjects enrolled in another interventional clinical study in the last 4 weeks or in an exclusion period following participation in another clinical trial
- •Subject who have a history of alcohol abuse
- •Subjects having diarrhea within the preceding 4-weeks
- •Subjects with severe life-threatening illness, severe evolutive or chronic pathology
- •Immune-suppressed subjects
- •Subjects with benign peptic ulcer or pre-malignant or malignant lesion
- •Subjects presenting with an infection of the gastrointestinal tract
- •Subjects with any past severe gastro-intestinal or metabolic pathology
- •Subjects with history of Helicobacter pylori eradication therapy
- •Subjects with history of cardiac or renal clinically significant disease
- •Subjects that have had any surgery or intervention requiring general anesthesia in the last 4 weeks, or that have any planned
- •Subjects with allergy or hypersensitivity against the medication for the eradication of Helicobacter pylori
- •Subjects taking treatments likely to interfere with the evaluation of study parameters.
- •Subjects with allergy or hypersensitivity to any component of the study products
研究组 & 干预措施
1 - Test
Experimental
干预措施: 1 - Fermented dairy drink (Other)
2 - Placebo
Placebo Comparator
干预措施: 2 - Acidified dairy drink (Other)
结局指标
主要结局
Occurrence of AAD
时间窗: From Day 0 to Day 28
次要结局
- Duration of AAD(From Day 0 to Day 28)
- Time to event of AAD(From Day 0 to Day 28)
- Occurrence of Clostridium difficile Associated Diarrhea(From Day 0 to Day 28)
- Time to event of Clostridium difficile Associated Diarrhea(From Day 0 to Day 28)
- Duration of Clostridium difficile Associated Diarrhea(From Day 0 to Day 28)
- Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting)(From Day 0 to Day 28)
- Score of gastrointestinal symptoms(From Day 0 to Day 28)
研究者
研究点 (2)
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