Analyzing IBS to Identify Biomarkers and Microbiome Signatures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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IBS, Diarrhoea Predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Procedure: endoscopy for tissue biopsy
* Other: Blood Sample
* Other: Stool Sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IBS-D patients<br>Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples. | Procedure: endoscopy for tissue biopsy<br>* endoscopy to obtain tissue biopsy for analysis of biomarker status<br>* Other names: Sigmoidoscopy;Other: Blood Sample<br>* Blood draw to evaluate serotonin and Vit D level.<br>Other: Stool Sample<br>* Stool sample to evaluate microbiome fingerprint.<br>|
| Other: Healthy Controls<br>Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples. | Procedure: endoscopy for tissue biopsy<br>* endoscopy to obtain tissue biopsy for analysis of biomarker status<br>* Other names: Sigmoidoscopy;Other: Blood Sample<br>* Blood draw to evaluate serotonin and Vit D level.<br>Other: Stool Sample<br>* Stool sample to evaluate microbiome fingerprint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, biomarkers, Vitamin D, Serotonin