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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00235326
Enrollment
4561
Registered
2005-10-10
Start date
2002-01-31
Completion date
2008-08-31
Last updated
2009-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

residents of Walkerton ontario at outbreak

Brief 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).

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

Interventions

None listed

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Number of Participants With Post Infectious Irritable Bowel Syndrome8 years

Countries

Canada

Participant flow

Recruitment details

Residents of Walkerton in may 2000

Pre-assignment details

Age less than 16, non-residents of walkerton, premorbid Inflammatory Bowel disease(IBD) /Irritable bowel syndrome(IBS)

Participants by arm

ArmCount
Unexposed to Gastroenteritis1,575
Exposed to Gastroenteritis2,986
Total4,561

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up7461,400

Baseline characteristics

CharacteristicExposed to GastroenteritisUnexposed to GastroenteritisTotal
Age, Categorical
<=18 years
907 Participants471 Participants1378.0 Participants
Age, Categorical
>=65 years
269 Participants199 Participants468.0 Participants
Age, Categorical
Between 18 and 65 years
1810 Participants905 Participants2715.0 Participants
Age Continuous34.97 years
STANDARD_DEVIATION 21.61
36.96 years
STANDARD_DEVIATION 22.76
35.66 years
STANDARD_DEVIATION 22.03
Region of Enrollment
Canada
2986 participants1575 participants4561.0 participants
Sex: Female, Male
Female
1665 Participants892 Participants2557.0 Participants
Sex: Female, Male
Male
1321 Participants683 Participants2004.0 Participants

Outcome results

Primary

Number of Participants With Post Infectious Irritable Bowel Syndrome

Time frame: 8 years

ArmMeasureValue (NUMBER)
Unexposed to GastroenteritisNumber of Participants With Post Infectious Irritable Bowel Syndrome23 participants
Exposed to GastroenteritisNumber of Participants With Post Infectious Irritable Bowel Syndrome114 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026