Analyzing IBS to Identify Biomarkers and Microbiome Signatures
Primary Purpose
Diarrhoea Predominant Irritable Bowel Syndrome, IBS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
endoscopy for tissue biopsy
Blood Sample
Stool Sample
Sponsored by
About this trial
This is an interventional basic science trial for Diarrhoea Predominant Irritable Bowel Syndrome focused on measuring microbiome, biomarkers, Vitamin D, Serotonin
Eligibility Criteria
Inclusion criteria:
IBS-D subjects:
- Patients who fulfill IBS-D criteria, without causes of active inflammation.
- active symptoms for at least 2 months
- diagnosed at least 6 months prior to enrollment
Healthy Control:
- Healthy control patients should have no active infection or inflammation.
Exclusion criteria:
- does not meet inclusion criteria
- will not participate in blood draw, stool sample donation, or endoscopy
- history of acute illness within 3 months of testing
- any fecal transplant history
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
IBS-D patients
Healthy Controls
Arm Description
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
Outcomes
Primary Outcome Measures
Serotonin level
2 blood vials will be drawn during the flexible sigmoidoscopy or colonoscopy procedure, and serotonin levels will be drawn from one of these blood samples.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419963
Brief Title
Analyzing IBS to Identify Biomarkers and Microbiome Signatures
Official Title
A New Dimension in Modeling Irritable Bowel Syndrome (IBS) to Elucidate Novel Diagnostic Biomarkers and Microbiome Signatures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
December 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Microbiota from fecal samples from IBS-D patients, in combination with vitamin D supplementation added to our 3-D immunocompetent intestinal models will establish a high fidelity disease model to achieve our long-term goal to understand the relationship between gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention.
Detailed Description
The pathophysiology of IBS is not well understood. Preliminary studies support IBS-D patients with varied microbiome fingerprints, vitamin D levels, and blood serotonin levels compared to non-IBS patients. The investigators have novel 3-D immunocompetent intestinal models to establish a new model of high fidelity disease to examine the relationship of IBS-D patients gut microbiome, with supplemental vitamin D levels, and the relationship of blood serotonin and vitamin D levels. IBS-D patients and healthy controls will be asked to provide a fecal sample, a biopsy sample of colonic tissue obtained during a clinically appropriate flexible sigmoidoscopy or colonoscopy, and a blood sample. There will be 1-2 office visits. One visit will last 30 minutes, the second visit no longer than 3 hours. This study is funded by a combined MAYO-Arizona State University seed grant. The samples will be analyzed at ASU. Our long-term goal is to understand the relationship between gut microbiome, vitamin D levels, host gene expression, serotonin levels, and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention of this highly prevalent disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea Predominant Irritable Bowel Syndrome, IBS
Keywords
microbiome, biomarkers, Vitamin D, Serotonin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBS-D patients
Arm Type
Other
Arm Description
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
Arm Title
Healthy Controls
Arm Type
Other
Arm Description
Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
Intervention Type
Procedure
Intervention Name(s)
endoscopy for tissue biopsy
Other Intervention Name(s)
Sigmoidoscopy
Intervention Description
endoscopy to obtain tissue biopsy for analysis of biomarker status
Intervention Type
Other
Intervention Name(s)
Blood Sample
Intervention Description
Blood draw to evaluate serotonin and Vit D level.
Intervention Type
Other
Intervention Name(s)
Stool Sample
Intervention Description
Stool sample to evaluate microbiome fingerprint.
Primary Outcome Measure Information:
Title
Serotonin level
Description
2 blood vials will be drawn during the flexible sigmoidoscopy or colonoscopy procedure, and serotonin levels will be drawn from one of these blood samples.
Time Frame
Study Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
IBS-D subjects:
Patients who fulfill IBS-D criteria, without causes of active inflammation.
active symptoms for at least 2 months
diagnosed at least 6 months prior to enrollment
Healthy Control:
- Healthy control patients should have no active infection or inflammation.
Exclusion criteria:
does not meet inclusion criteria
will not participate in blood draw, stool sample donation, or endoscopy
history of acute illness within 3 months of testing
any fecal transplant history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Foxx-Orenstein, DO
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Analyzing IBS to Identify Biomarkers and Microbiome Signatures
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