Clinical trial NCT02419963: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea Predominant Irritable Bowel Syndrome
IBS
Keywords: microbiome
biomarkers
Vitamin D
Serotonin
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Serotonin level
timeFrame: Study Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Amy Foxx-Orenstein, DO
role: PRINCIPAL_INVESTIGATOR
References: