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Trial record 1 of 3 for:    17631127 [PUBMED-IDS]
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Serine Proteases in Gastrointestinal Function and Irritable Bowel Syndrome (IBS)

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ClinicalTrials.gov Identifier: NCT01072916
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ian Carroll, PhD, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date February 18, 2010
First Posted Date February 22, 2010
Last Update Posted Date March 11, 2016
Study Start Date February 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2013)
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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01072916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 15, 2013)
intestinal permeability [ Time Frame: 6hrs following recruitment ]
We will analyze sugar concentrations in urine to determine the level of intestinal permeability.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serine Proteases in Gastrointestinal Function and Irritable Bowel Syndrome (IBS)
Official Title The Role of Serine-Proteases in Gastrointestinal Function and Irritable Bowel Syndrome
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine and Stool.
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).
Condition Colon, Irritable
Intervention Not Provided
Study Groups/Cohorts
  • IBS
    Subjects with IBS-D
  • Healthy
    Healthy Subjects
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February 19, 2010)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01072916
Other Study ID Numbers 08-1149
R24DK067674 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ian Carroll, PhD, University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ian M Carroll, PhD UNC Chapel Hill Department of Gastroenterology and Hepatology
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2014