Serine Proteases in Gastrointestinal Function and Irritable Bowel Syndrome (IBS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ian Carroll, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01072916
First received: February 18, 2010
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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
Colon, Irritable

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Serine-Proteases in Gastrointestinal Function and Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • fecal serine protease activity [ Time Frame: protease activity determined at at recruitment ] [ Designated as safety issue: No ]
    we will use an elisa-based method to measure the activity of serine proteases in fecal samples from IBS and HC subjects


Secondary Outcome Measures:
  • intestinal permeability [ Time Frame: 6hrs following recruitment ] [ Designated as safety issue: No ]
    We will analyze sugar concentrations in urine to determine the level of intestinal permeability.


Biospecimen Retention:   Samples Without DNA

Urine and Stool.


Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
IBS
Subjects with IBS-D
Healthy
Healthy Subjects

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men and women of any race or ethnicity at least 18 years or older who have Diarrhea predominant Irritable Bowel Syndrome (D-IBS, n = 30) and healthy controls (n = 30).

Criteria

Inclusion Criteria:

  • Any sex, race, or ethnicity.
  • At least 18 years of age (no upper age limit).
  • D-IBS patients must meet Rome III criteria for IBS and must have been evaluated by a physician to exclude other diseases that could explain the symptoms. For the latter, patients self statement is acceptable (no official document is required).
  • Participation in Dr. Whitehead's 'heterogeneity of IBS' and/or Dr. Ringel's 'intestinal inflammation in patients with D-IBS' research study.

Exclusion Criteria:

  • Healthy controls must have no significant or recurring gastrointestinal symptoms.
  • Patients and healthy controls should not have a serious, unstable medical condition.
  • Patients and healthy controls must have had no gastrointestinal tract surgery other than appendectomy or cholecystectomy.
  • Patients and healthy controls must not be pregnant (by self-report). Pregnant women will not be allowed to participate as pregnancy can affect gastrointestinal symptoms.
  • Patients and healthy controls must not have a history of inflammatory bowel disease, celiac disease, or other diagnosis that could explain chronic or recurring bowel symptoms in IBS patients or controls.
  • Patients and healthy controls should have no history of lactose malabsorption (by self-report).
  • Patients and healthy controls should have no history of clinical symptoms of acute infections during the last 8 weeks prior to enrolment in the study.
  • Patients and healthy controls should have no history of anti-inflammatory agents including aspirin, non-aspirin, non-steroid anti-inflammatory (NSAID) or steroids in the last four weeks prior to study enrollment.
  • Patients should not intentionally consume probiotics or undergo antibiotic treatment during the last 4 weeks prior to enrolment in the study. If the subject consumed any of these medications, a washout period of 4 weeks will be required).
  • Patients must have no history of fainting or light headedness during periods of fasting.
  • Patients must not have diabetes mellitus, or any similar conditions, that would cause an adverse reaction to the sugar drink.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072916

Locations
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
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Ian M Carroll, PhD UNC Chapel Hill Department of Gastroenterology and Hepatology
  More Information

Publications:
Responsible Party: Ian Carroll, PhD, Assistant Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01072916     History of Changes
Other Study ID Numbers: 08-1149, R24DK067674
Study First Received: February 18, 2010
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Colon, Irritable
Microbiota

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 20, 2014