Clinical Trials Directory

Trials / Completed

CompletedNCT01072903

The Role of Intestinal Inflammation in Irritable Bowel Syndrome (IBS)

The Role of Intestinal Inflammation in the Pathophysiology of IBS

Status
Completed
Phase
Study type
Observational
Enrollment
78 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The research project addresses the following hypotheses (A) the normal balance of beneficial and detrimental commensal intestinal bacteria is deranged in IBS, with selective alterations in clinically defined patient subsets i.e., diarrhea predominant IBS (D-IBS) and post-infectious IBS (PI-IBS); (B) these changes in intestinal microflora are associated with sub-clinical mucosal inflammation and activation of the mucosal immune system; and (C) activation of the mucosal immune system leads to alterations in gastrointestinal (GI) functions (i.e., motility and sensation) and functional symptoms.

Detailed description

There are two main aims in the research study. The first aim is to determine whether sub-clinical mucosal inflammation occurs in patients with D-IBS by identifying alterations in mucosal markers for inflammation (inflammatory cytokines and inflammation-related mediators). The second aim is to investigate whether the identifiable alterations in inflammatory markers are associated with specific abnormalities in intestinal motor and sensory functions that are relevant to the pathophysiology of IBS.

Conditions

Timeline

Start date
2009-01-01
Primary completion
2012-07-01
Completion
2012-07-01
First posted
2010-02-22
Last updated
2013-12-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01072903. Inclusion in this directory is not an endorsement.