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临床试验/NCT04138225
NCT04138225Unknown不适用

Assessing the Ecological Role of Yeasts in the Human Gut and Their Impact on Gastrointestinal Disorders

Grace Ward1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年9月23日最近更新:
适应症

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

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

发起方
Grace Ward
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Grace Ward

PhD Researcher

University of Reading

研究点 (1)

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