The Ecological Role of Yeasts in the Human Gut

NCT ID: NCT04138225

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-23

Study Completion Date

2021-09-23

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome Inflammatory Bowel Diseases Gastrointestinal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Healthy

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

No interventions assigned to this group

Irritable bowel syndrome (IBS)

Participants with Rome IV diagnosed IBS

No interventions assigned to this group

Inflammatory bowel disease (IBD)

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Berkshire Hospital

UNKNOWN

Sponsor Role collaborator

Grace Ward

OTHER

Sponsor Role lead

Responsible Party

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Grace Ward

PhD Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Reading

Reading, Berkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Grace Newland, MSc

Role: CONTACT

07956783096

Facility Contacts

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Grace Newland, MSc

Role: primary

07956783096

Other Identifiers

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YIGV1

Identifier Type: -

Identifier Source: org_study_id

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