Analyzing IBS to Identify Biomarkers and Microbiome Signatures

IBS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419963
• Other study ID #: 14-008799
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: July 5, 2017
• Start date: May 2015
• Est. completion date: December 12, 2016

Study information

• Verified date: July 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 12, 2016
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea Predominant Irritable Bowel Syndrome
• IBS
• Irritable Bowel Syndrome
• Syndrome

Intervention

Procedure:
• endoscopy for tissue biopsy
endoscopy to obtain tissue biopsy for analysis of biomarker status

Other:
• Blood Sample
Blood draw to evaluate serotonin and Vit D level.
• Stool Sample
Stool sample to evaluate microbiome fingerprint.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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