The Effect of Probioticson Bloating in IBS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- In-vitro production (quantified) of hydrogen and methane in feces
研究概览
简要总结
The purpose of the study is to establish an in-vitro method to evaluate the effect of probiotics on gas production in feces (hydrogen and methane)
详细描述
The objective of this study is to establish a model for screening probiotic bacteria in the treatment of meteorism symptoms (feeling of air in the stomach) with otherwise healthy adult women. As excessive bacterial gas production in the intestine is the most likely mechanism behind meteorism, we will examine eventual changes of the production of gases (hydrogen and methane) before and after administration of Trevis®. For screening of Trevis® we will apply a combination of clinical examination and a laboratory model for the determination of gastrointestinal gas production (a new method in connection with studies on probiotics). The results will be compared with the test person's specification of their health, both with respect to gastrointestinal function and in general through questionnaires. The background for the project will be described in the following.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Female test persons with symptoms of meteorism, the age of > 18 years, completely integrated in the Danish society (including nutrition), and no previous abdominal surgery besides from appendicectomy (advertisement in a local newspaper for test persons).
排除标准
- •Lactose and sorbitol intolerant persons (based on hydrogen breath tests).
- •Persons with chronic ingestion of medicine, that might have an effect on gut bacterial flora or bowel motility.
- •Persons taking antibiotics within 2 month prior to the trial
- •Persons with diagnosed gastrointestinal disease other than IBS.
- •Persons not able to understand and/or read Danish.
- •Persons under age and persons with obvious problems remembering and sticking to the protocol (persons with dementia, psychological illness etc.)
结局指标
主要结局
In-vitro production (quantified) of hydrogen and methane in feces
Recovery of ingested bacteria in feces by PCR
次要结局
- Quality of life (SF36-danish version)
- VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence
- Abdominal height in lying position, waist circumference, weight