Serine Proteases in Gastrointestinal Function and Irritable Bowel Syndrome (IBS)
|ClinicalTrials.gov Identifier: NCT01072916|
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : March 11, 2016
The proposed pilot project for this seed grant focuses on the role of intestinal serine-proteases in the pathogenesis of diarrhea-predominant IBS (D-IBS). In this study we will further assess serine-protease activity in patients with D-IBS and also explore a possible mechanism by which these proteases can lead to alterations in intestinal physiology and symptoms in these patients.
The general hypotheses for the proposed research are that (A) the levels of fecal serine-protease in patients with D-IBS are abnormally increased (B) this abnormal serine-protease activity leads to/is associated with an abnormal increase in intestinal permeability and therefore enables (C) chronic stimulation and activation of the mucosal immune system in these patients. In addition, it is aim to determine whither periodontal inflammation is associated with intestinal permeability and serine protease activity.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||The Role of Serine-Proteases in Gastrointestinal Function and Irritable Bowel Syndrome|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Subjects with IBS-D
- fecal serine protease activity [ Time Frame: protease activity determined at at recruitment ]we will use an elisa-based method to measure the activity of serine proteases in fecal samples from IBS and HC subjects
- intestinal permeability [ Time Frame: 6hrs following recruitment ]We will analyze sugar concentrations in urine to determine the level of intestinal permeability.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072916
|United States, North Carolina|
|University of North Carolina at Chapel Hill, Program in Digestive Health and the Department of Gastroenterology and Hepatology|
|Chapel Hill, North Carolina, United States, 27599-7080|
|Principal Investigator:||Ian M Carroll, PhD||UNC Chapel Hill Department of Gastroenterology and Hepatology|