The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Area under the Curve of Hydrogen Gas on Lactulose Breath Test
研究概览
简要总结
Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Rome III criteria for IBS
- •Willing to undergo dietary intervention
排除标准
- •History of Gastric, Small Bowel or Colonic Surgery
- •History of Inflammatory Bowel Disease
- •Celiac Disease
- •Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives
- •On a pre specified diet
研究组 & 干预措施
High Factor Diet
Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.
干预措施: Factor Altered Diet (Dietary Supplement)
Low Factor Diet
Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.
干预措施: Factor Altered Diet (Dietary Supplement)
结局指标
主要结局
Area under the Curve of Hydrogen Gas on Lactulose Breath Test
时间窗: 5 hours
次要结局
- Change in Area Under the Curve on Lactulose Breath Test from Baseline(5 hours)
- Change in IBS Symptom Severity Score from Baseline(3 weeks)
研究者
Dr. Stephen Vanner
Professor of Medicine
Queen's University