The Ecological Role of Yeasts in the Human Gut

Inflammatory Bowel Diseases Clinical Trial

— YIG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04138225
• Other study ID #: YIGV1
• Status: Recruiting
• Start date: September 23, 2018
• Est. completion date: September 23, 2021

Study information

• Verified date: October 2019
• Source: University of Reading
• Contact: Grace Newland, MSc
• Phone: 07956783096
• Email: grace.ward[@]pgr.reading.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 23, 2021
• Est. primary completion date: May 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (3)

Lead Sponsor	Collaborator
Grace Ward	Guy's and St Thomas' NHS Foundation Trust, Royal Berkshire Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yeast species in gut	Measured from stool samples using fluorescence in situ hybridisation	Baseline
Primary	Metabolic profile	Measures from stool, urine and blood samples using nuclear magnetic resonance spectroscopy	Baseline
Secondary	Calprotectin	Measured using ELISA	Baseline
Secondary	Lactorferrin	Measured using ELISA	Baseline