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

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00235326
First received: October 6, 2005
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

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).


Condition
Irritable Bowel Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Number of Participants With Post Infectious Irritable Bowel Syndrome [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 4561
Study Start Date: January 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
2
Unexposed to gastroenteritis
1
Exposed to gastroenteritis

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

residents of walkerton

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235326

Locations
Canada, Ontario
Walkerton
Walkerton, Ontario, Canada, N0G 2V0
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: John k Marshall, MD, MSc McMaster University
  More Information

No publications provided

Responsible Party: John Marshall, Mcmaster University
ClinicalTrials.gov Identifier: NCT00235326     History of Changes
Other Study ID Numbers: 02-026; 05-346
Study First Received: October 6, 2005
Results First Received: February 5, 2009
Last Updated: March 16, 2009
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
residents of Walkerton ontario at outbreak

Additional relevant MeSH terms:
Gastroenteritis
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 11, 2014