Analyzing IBS to Identify Biomarkers and Microbiome Signatures

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.

Study Overview

• Status: Completed
• Conditions: IBS; Diarrhoea Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Procedure: endoscopy for tissue biopsy; Other: Blood Sample; Other: Stool Sample

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Amy Foxx-Orenstein, DO, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): December 12, 2016

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D; biomarkers; Serotonin; microbiome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: 14-008799