Irritable Bowel SyndromeYIGNCT04138225
The Ecological Role of Yeasts in the Human Gut
An observational study of Irritable Bowel Syndrome and Inflammatory Bowel Diseases, run by Grace Ward at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Gastrointestinal Disease
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2018to 23 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University, community and primary care clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading
Reading, Berkshire, RG6 6AH
Grace Newland, MSc, 07956783096, grace.ward@pgr.reading.ac.uk
About this study
Official title: 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.
- Keywords
- yeast, mycology, gut, microbiota, gastrointestinal disorders
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Yeast species in gut
Measured from stool samples using fluorescence in situ hybridisation
Measured: Baseline
Metabolic profile
Measures from stool, urine and blood samples using nuclear magnetic resonance spectroscopy
Measured: Baseline
Secondary outcomes (2)
Calprotectin
Measured using ELISA
Measured: Baseline
Lactorferrin
Measured using ELISA
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start23 Sep 2018
- Primary completion23 May 2020 (estimated)
- Study completion23 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grace Ward
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Royal Berkshire Hospital
- Responsible party
- Sponsor-investigator, Grace Ward, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138225
- Sponsor's protocol ID
- YIGV1
- Acronym
- YIG
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Ecological Role of Yeasts in the Human Gut and Their Impact on Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT04138225
- Acronym / sponsor ID
- YIG / YIGV1
- Keywords
- yeast, mycology, gut, microbiota, gastrointestinal disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Grace WardUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Royal Berkshire Hospital
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 23 May 2020 (estimated)
- Study completion
- 23 Sep 2021 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University, community and primary care clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Yeast species in gut
Time frame: Baseline
Measured from stool samples using fluorescence in situ hybridisation
Metabolic profile
Time frame: Baseline
Measures from stool, urine and blood samples using nuclear magnetic resonance spectroscopy
2 secondary outcomes
Calprotectin
Time frame: Baseline
Lactorferrin
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome and Inflammatory Bowel Diseases, run by Grace Ward at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace Newland, MSc (07956783096, grace.ward@pgr.reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yeast species in gut (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.