Clinical trial NCT04138225: The Ecological Role of Yeasts in the Human Gut
Official title: Assessing the Ecological Role of Yeasts in the Human Gut and Their Impact on Gastrointestinal Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Gastrointestinal Disease
Keywords: yeast
mycology
gut
microbiota
gastrointestinal disorders
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Royal Berkshire Hospital
First posted: 2019-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University, community and primary care clinics

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Yeast species in gut
timeFrame: Baseline
measure: Metabolic profile
timeFrame: Baseline
Secondary outcomes:
measure: Calprotectin
timeFrame: Baseline
measure: Lactorferrin
timeFrame: Baseline
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References: