The Ecological Role of Yeasts in the Human Gut | NCT04138225

Studies
The Ecological Role of Yeasts in the Human Gut

NCT04138225

Sponsor

Grace Ward

Status

Unknown status

Last Update Posted

Oct 28, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Gastrointestinal Disease

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2018Actual

Primary Completion Date

May 23, 2020Estimated

Completion Date

Sep 23, 2021Estimated

First Submitted Date

Oct 22, 2019

First Submission Date that Met QC Criteria

Oct 22, 2019

First Posted Date

Oct 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2019

Last Update Posted Date

Oct 28, 2019Actual

Name	Class
Guy's and St Thomas' NHS Foundation Trust	OTHER
Royal Berkshire Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

University, community and primary care clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Grace Newland, MSc	Contact	07956783096		grace.ward@pgr.reading.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Reading	Recruiting	Reading	Berkshire	RG6 6AH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome
D015212	Inflammatory Bowel Diseases
D005767	Gastrointestinal Diseases

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided