Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario

March 16, 2009 updated by: McMaster University

Acute Bacterial dysentery leads to chronic symptoms of disturbed bowel habit in a minority of individuals. This condition known as post infectious irritable bowel syndrome (PI-IBS) remains poorly understood. This could allow material in the bowel to reach deeper tissues of the bowel wall leading to inflammation and changes in muscle and nerve function. This is also early evidence that genetic programming of people with PI-IBS prevents them from turning off inflammation once it begins. Literature suggests that IBS may develop at greater rates in individuals with pro-inflammatory genotype and that these individuals may be at increased risk of inflammatory bowel diseases (IBD).

Study Overview

Status

Completed

Conditions

Irritable Bowel Syndrome

Detailed Description

This research will study chronic gastrointestinal problems in the residents of Walkerton, Ontario region. Determine whether acute bacterial infection is a risk factor for development of inflammatory bowel disease using the population of Walkerton as a cohort. We hypothesize that exposure to bacterial infection leads to development of post infectious irritable bowel syndrome which is associated with an increase in intestinal permeability and immune activation with low grade intestinal inflammation and that this sequence of events will trigger inflammatory bowel disease in genetically susceptible individuals

Study Type

Observational

Enrollment (Actual)

4561

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Walkerton, Ontario, Canada, N0G 2V0
    - Walkerton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

residents of walkerton

Description

Inclusion Criteria:

Participants must be residents of the Walkerton, Ontario region at the time of Outbreak who consented to the study

Exclusion Criteria:

Non residents of Walkerton Ontario at the time of outbreak

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
2 Unexposed to gastroenteritis
1 Exposed to gastroenteritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Post Infectious Irritable Bowel Syndrome Time Frame: 8 years	8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

Principal Investigator: John k Marshall, MD, MSc, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria