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NCT00235326 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00235326
Other study ID # 02-026; 05-346
Secondary ID
Status Completed
Phase N/A
First received October 6, 2005
Last updated March 16, 2009
Start date January 2002
Est. completion date August 2008

Study information
Verified date March 2009
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility
Status Completed
Enrollment 4561
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Walkerton Walkerton Ontario

Sponsors (1)
Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Post Infectious Irritable Bowel Syndrome 8 years No
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