Expired Study
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Scottsdale, Arizona 85259


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02419963


Primary Contact:

Principal Investigator
Amy Foxx-Orenstein, DO
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Scottsdale, Arizona 85259
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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