Analyzing IBS to Identify Biomarkers and Microbiome Signatures

Mayo Clinic

Status: Completed

Conditions: Diarrhoea Predominant Irritable Bowel Syndrome; IBS

Treatments: Other: Blood Sample; Procedure: endoscopy for tissue biopsy; Other: Stool Sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02419963

14-008799

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

IBS-D patients

Other group

Description:

Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.

Treatment:

Other: Stool Sample

Other: Blood Sample

Procedure: endoscopy for tissue biopsy

Healthy Controls

Other group

Description:

Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.

Treatment:

Other: Stool Sample

Other: Blood Sample

Procedure: endoscopy for tissue biopsy