IBS Clinical Trial
Official title:
A New Dimension in Modeling Irritable Bowel Syndrome (IBS) to Elucidate Novel Diagnostic Biomarkers and Microbiome Signatures
Verified date | July 2017 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 12, 2016 |
Est. primary completion date | December 12, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Study Day 2 |
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