NCT01099696已完成不适用
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Benefit of a Probiotic (Bifidobacterium Infantis 35624) in Healthy Subjects With a History of Abdominal Discomfort and Bloating
Procter and Gamble11 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2010年4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
- 302
- 试验地点
- 11
- 主要终点
- The change in abdominal discomfort and bloating
研究概览
简要总结
This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
详细描述
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men and non-pregnant, non-lactating women aged 18 to 75 years of age;
- •Body Mass Index (BMI) < or = 40;
- •if female, postmenopausal or using adequate contraception
- •if over 50 years of age, have had a colonoscopy performed in the previous 5 years with findings that are normal for this population
- •be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria during the study and be willing to refrain from taking any medications or preparations that treat lower digestive upsets
- •have experienced abdominal discomfort and bloating at least twice a week, on average, over the last 3 months.
排除标准
- •have been under a physician's care for functional bowel disorders within the past year or have taken prescription medication for functional bowel disorders within the past year;
- •have alarm symptoms suggestive of an underlying disease;
- •have prior GI surgery (appendectomy and hernia repair are not excluded and cholecystectomy at least 3 years ago is not excluded);
- •have a significant acute or chronic coexisting illness or condition;
- •have used systemic steroidal agents within the last 30 days;
- •have used oral or systemic antibiotics within the last 30 days;
- •have used probiotics at least 3 times a week within the last 30 days;
结局指标
主要结局
The change in abdominal discomfort and bloating
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (11)
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