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.