跳至主要内容
临床试验/NCT00589771
NCT00589771已完成3 期

Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome

Aga Khan University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
72
试验地点
1
主要终点
Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features

研究概览

简要总结

Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It ameliorates intestinal injury and inflammation caused by a wide variety of enteric pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant IBS and its effect on quality of life. We also plan to assess the changes in the relative production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8 and TNFα).

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diarrhea-predominant IBS satisfying ROME III criteria.
  • Adults aged 18-70

排除标准

  • Pregnant and lactating females
  • Inflammatory bowel disease and other systemic disease
  • Patients on anti-diarrheal and antibiotics drugs
  • Patients with any ongoing infection
  • Not willing to participate
  • Allergy to any of Saccharomyces boulardii components
  • Central venous catheter carriers
  • Other probiotics e.g., Lactobacillus and Bifidobacterium

研究组 & 干预措施

A

Experimental
  1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks.
  2. Ispahgula husk 1 Tsf daily after dinner for six weeks.

干预措施: Saccharomyces boulardii (Drug)

B

Placebo Comparator
  1. Capsule Placebo TDS for six weeks.
  2. Ispaghula husk 1 Tsf daily after dinner for six weeks

干预措施: Placebo (Drug)

结局指标

主要结局

Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features

时间窗: 6 weeks

次要结局

  • Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug(6 weeks)

研究者

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

Zaigham Abbas

Consultant Gastroenterologist

Aga Khan University

研究点 (1)

Loading locations...

相似试验