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临床试验/NCT01837472
NCT01837472已完成2 期

Evaluating The Effects of Probiotics on Symptoms of Patients With Irritable Bowel Syndrome

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
132
试验地点
1
主要终点
Abdominal pain

研究概览

简要总结

Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome (IBS), but few reports are available on the effects of multistrain probiotics and there are few reports available in this regard from our society. Thus, we investigated if probiotics are effective in our patients as well. We hypothesize that the multistrain probiotic Balance containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains, and Streptococcus thermophiles 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

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

Probiotic

Experimental

干预措施: Probiotic (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Abdominal pain

时间窗: Up to 6 weeks

Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks

次要结局

  • Quality of Life(Up to 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Gholamrezaei

Dr.

Isfahan University of Medical Sciences

研究点 (1)

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