A Combination of Yoghurt Bacteria and Acid Lactase From Aspergillus Oryzae Improves Lactose Digestion in Lactose Malabsorbers More Reliably Than Preparations Containing Acid Lactase or Yoghurt Bacteria Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Increase in hydrogen concentration in the breath (H2-exhalation breath test)
研究概览
简要总结
Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose malabsorbers than unfermented dairy products. The intake of dietary supplements containing acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose malabsorbers. It is hypothized that the combination preparation will be more effective and/or will show a more reliable effect than the two mono-preparations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of African or Asian origin.
- •Older than 18 years
- •Written informed consent
排除标准
- •Participation in a clinical study with a drug or a medical product withing the last 30 days;
- •Inability to comply with the study protocol;
- •Allergy to milk protein;
- •Intolerance against lactase preparations;
- •Known metabolic or gastrointestinal diseases which affect the absorption, metabolism or excretion of food components except lactose maldigestion;
- •Intake of drugs influencing resorption of food components or gastrointestinal motility;
- •Surgery within the last three months which still affect the current status of health;
- •Psychiatric diseases
- •Epilepsia
- •Risk for suicide
- •Eating disorders, e.g. anorexia, bulimia
- •Alcohol or drug abuse
- •Legal incapacity
结局指标
主要结局
Increase in hydrogen concentration in the breath (H2-exhalation breath test)
时间窗: Every 20 minutes for 4 hours
次要结局
未报告次要终点