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

NCT01072916 | Completed

• 2 other identifiers: 08-1149R24DK067674
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon, Irritable

Keywords

Colon, Irritable; Microbiota

Outcome Measures

Primary Outcomes (1)

• fecal serine protease activity

  we will use an elisa-based method to measure the activity of serine proteases in fecal samples from IBS and HC subjects

  protease activity determined at at recruitment

Secondary Outcomes (1)

• intestinal permeability

  6hrs following recruitment

Study Arms (2)

IBS

Subjects with IBS-D

Healthy

Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill, Program in Digestive Health and the Department of Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599-7080, United States

Location

Related Publications (2)

• Kassinen A, Krogius-Kurikka L, Makivuokko H, Rinttila T, Paulin L, Corander J, Malinen E, Apajalahti J, Palva A. The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subjects. Gastroenterology. 2007 Jul;133(1):24-33. doi: 10.1053/j.gastro.2007.04.005. Epub 2007 Apr 14.

  PMID: 17631127 BACKGROUND

• Roka R, Rosztoczy A, Leveque M, Izbeki F, Nagy F, Molnar T, Lonovics J, Garcia-Villar R, Fioramonti J, Wittmann T, Bueno L. A pilot study of fecal serine-protease activity: a pathophysiologic factor in diarrhea-predominant irritable bowel syndrome. Clin Gastroenterol Hepatol. 2007 May;5(5):550-5. doi: 10.1016/j.cgh.2006.12.004. Epub 2007 Mar 2.

  PMID: 17336590 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and Stool.

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ian M Carroll, PhD

  UNC Chapel Hill Department of Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 11, 2016

Record last verified: 2014-04

Locations

US (1)