Assessing the Ecological Role of Yeasts in the Human Gut and Their Impact on Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Yeast species in gut
研究概览
简要总结
Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) (categorised into Crohn's disease (CD) and ulcerative colitis (UC)) are chronic gut disorders with debilitating symptoms that profoundly impact quality of life, healthcare systems and the economy through lost work days. IBS is common with a prevalence of up to 22%, whereas IBD has a prevalence of 0.3% for CD and 0.5% for UC in Europe. Despite a suggested immunological and genetic aspect of IBD, the causes of IBS and IBD are unknown, however, both have been linked to yeasts in the gut.
Due to their lower abundance (constituting only around 0.1% of the total microorganisms in the gut) yeasts have been less studied than bacteria. More recently, significantly altered diversity and composition of yeasts have been identified in IBS and IBD but further investigation is required to fully develop the role of yeasts in the gut.
This observational study will assess yeasts and their function in the gut, comparing diseased subjects with healthy controls. The overall aim is to determine if yeasts could be targeted as a potential therapeutic for IBS and IBD to provide relief to sufferers as well as reducing the burden on healthcare systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20-60 years old.
- •Either healthy or diagnosed with a gut disorder: Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) which may include Crohn's disease or ulcerative colitis.
- •In good general health.
- •Provided written informed consent and willing to participate in this study.
排除标准
- •Received antibiotics in the previous six months.
- •Consume prebiotics or probiotics on a regular basis (at least 3 times per week) in the last 2 weeks or intend to throughout the course of the study. (Examples of these include: Multibionta multivitamins, Danone Actimel yoghurt drink; Danone Activia yoghurt; Yakult fermented milk drink; Kellogg's Rice Krispies multigrain and Muller Vitality yoghurts/drinks).
- •Current use of immunosuppressive drugs.
- •Use of other medication which affects gastrointestinal motility and/or gut discomfort.
- •History of alcohol or drug misuse.
结局指标
主要结局
Yeast species in gut
时间窗: Baseline
Measured from stool samples using fluorescence in situ hybridisation
Metabolic profile
时间窗: Baseline
Measures from stool, urine and blood samples using nuclear magnetic resonance spectroscopy
次要结局
- Calprotectin(Baseline)
- Lactorferrin(Baseline)
研究者
Grace Ward
PhD Researcher
University of Reading
