Analyzing IBS to Identify Biomarkers and Microbiome Signatures

Not Applicable

Completed

• Conditions: Diarrhoea Predominant Irritable Bowel Syndrome; IBS
• Interventions: Procedure: endoscopy for tissue biopsy; Other: Blood Sample; Other: Stool Sample

• Registration Number: NCT02419963
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Study Start: 2015-05
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Stool Sample	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
IBS-D patients	endoscopy for tissue biopsy	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
IBS-D patients	Blood Sample	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
Healthy Controls	endoscopy for tissue biopsy	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
IBS-D patients	Stool Sample	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.
Healthy Controls	Blood Sample	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.

Primary Outcome Measures

Name	Time	Method
Serotonin level	Study Day 2	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States