Analyzing IBS to Identify Biomarkers and Microbiome Signatures



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:May 2015
End Date:December 2017

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A New Dimension in Modeling Irritable Bowel Syndrome (IBS) to Elucidate Novel Diagnostic Biomarkers and Microbiome Signatures

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.

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.

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
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Phone: 480-301-8598
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