The Ecological Role of Yeasts in the Human Gut (YIG)

October 24, 2019 updated by: Grace Ward

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

University, community and primary care clinics

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calprotectin
Time Frame: Baseline
Measured using ELISA
Baseline
Lactorferrin
Time Frame: Baseline
Measured using ELISA
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grace Ward

Collaborators

Guy's and St Thomas' NHS Foundation Trust
Royal Berkshire Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2018

Primary Completion (ANTICIPATED)

May 23, 2020

Study Completion (ANTICIPATED)

September 23, 2021

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (ACTUAL)

October 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YIGV1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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