Skip to main content
OpenTrials
Completed

NCT Number: NCT02419963

Analyzing IBS to Identify 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopy for tissue biopsy

Procedure

endoscopy to obtain tissue biopsy for analysis of biomarker status

Other names: Sigmoidoscopy

blood sample

Other

Blood draw to evaluate serotonin and Vit D level.

Stool sample

Other

Stool sample to evaluate microbiome fingerprint.

Primary outcomes

  1. Serotonin level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2015
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.