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

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.

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Key information

Conditions

Colon, Irritable Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Secondary outcomes

intestinal permeability

Time frame: 6hrs following recruitment

We will analyze sugar concentrations in urine to determine the level of intestinal permeability.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

The Role of Serine-Proteases in Gastrointestinal Function and Irritable Bowel Syndrome

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Feb 22, 2010
Registry last updated: Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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