The Ecological Role of Yeasts in the Human Gut

Study Overview
=================
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.

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

Conditions
-----------------
Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Gastrointestinal Disease

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Healthy participants are those without IBS, IBD or any other gastrointestinal disorder | |
| Irritable bowel syndrome (IBS)<br>Participants with Rome IV diagnosed IBS | |
| Inflammatory bowel disease (IBD)<br>Patients with IBD - either ulcerative colitis (UC) or Crohn's disease (CD) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yeast species in gut | Measured from stool samples using fluorescence in situ hybridisation | Baseline | 
| Metabolic profile | Measures from stool, urine and blood samples using nuclear magnetic resonance spectroscopy | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calprotectin | Measured using ELISA | Baseline | 
| Lactorferrin | Measured using ELISA | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gut, yeast, mycology, microbiota, gastrointestinal disorders