Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome
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
- 否
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
- Capsule Saccharomyces boulardii 250 mg TDS for six weeks.
- Ispahgula husk 1 Tsf daily after dinner for six weeks.
干预措施: Saccharomyces boulardii (Drug)
B
- Capsule Placebo TDS for six weeks.
- 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
Zaigham Abbas
Consultant Gastroenterologist
Aga Khan University
