Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Abdominal pain
研究概览
简要总结
Some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. Because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.
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
- Quadruple (Participant, Care Provider, 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
- •age between 18 and 65
- •diagnosis of IBS based on the Rome III criteria
- •willingness to participate
排除标准
- •receiving other probiotics compound during the study
- •receiving antibiotics during the study
研究组 & 干预措施
Lactol
干预措施: Lactol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Abdominal pain
时间窗: Up to 3 months
Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.
Diarrhea
时间窗: Up to 3 months
Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.
Constipation
时间窗: Up to 3 months
Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.
次要结局
未报告次要终点
研究者
Mozhdeh Zahiri
Dr.
Islamic Azad University, Najafabad Branch