The Ecological Role of Yeasts in the Human Gut

NCT04138225 | Unknown

• 1 other identifier: YIGV1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Gastrointestinal Disease

Keywords

yeast; mycology; gut; microbiota; gastrointestinal disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Calprotectin

  Baseline

• Lactorferrin

  Baseline

Study Arms (3)

Healthy

Healthy participants are those without IBS, IBD or any other gastrointestinal disorder

Irritable bowel syndrome (IBS)

Participants with Rome IV diagnosed IBS

Inflammatory bowel disease (IBD)

Patients with IBD - either ulcerative colitis (UC) or Crohn's disease (CD)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

University, community and primary care clinics

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grace Ward: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Royal Berkshire Hospital: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases; Gastroenteritis

Central Study Contacts

Grace Newland, MSc

CONTACT

07956783096; grace.ward@pgr.reading.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Researcher

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: September 23, 2018
• Primary Completion: May 23, 2020
• Study Completion: September 23, 2021
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

GB (1)