CClinicalTrials.gg
CompletedNCT00235326Updated Apr 22, 2009Results posted

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

An observational study in Irritable Bowel Syndrome, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-04-22.

Sponsored by McMaster University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,561
Ages
16 Years and older
Sex
All
01

Study 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).

Read the 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

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • residents of Walkerton ontario at outbreak
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 4,561 is above the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

residents of walkerton

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Non residents of Walkerton Ontario at the time of outbreak
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,561 participants (actual)

Groups and cohorts

  • 2

    Unexposed to gastroenteritis

  • 1

    Exposed to gastroenteritis

06

What researchers measure

Primary outcomes

  1. Number of Participants With Post Infectious Irritable Bowel Syndrome

    Time frame: 8 years

07

Results

Posted Apr 22, 2009

Participant flow

Residents of Walkerton in may 2000

Participant flow — Overall Study
MilestoneUnexposed to GastroenteritisExposed to Gastroenteritis
Started15752986
Completed8291586
Not completed7461400
Withdrew: Lost to follow-up7461400

Outcome measures

PrimaryNumber of Participants With Post Infectious Irritable Bowel Syndrome
Time frame:
8 years
Reported as:
Number · participants
Number of Participants With Post Infectious Irritable Bowel Syndrome
participantsUnexposed to GastroenteritisExposed to Gastroenteritis
Number of Participants With Post Infectious Irritable Bowel Syndrome23114

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Unexposed to GastroenteritisExposed to GastroenteritisTotal
<=18 years4719071378.0
Between 18 and 65 years90518102715.0
>=65 years199269468.0
Age Continuous
Age Continuous(years)Unexposed to GastroenteritisExposed to GastroenteritisTotal
Mean36.96 ± 22.7634.97 ± 21.6135.66 ± 22.03
Sex: Female, Male
Sex: Female, Male(Participants)Unexposed to GastroenteritisExposed to GastroenteritisTotal
Female89216652557.0
Male68313212004.0
Region of Enrollment
Region of Enrollment(participants)Unexposed to GastroenteritisExposed to GastroenteritisTotal
Canada157529864561.0
08

Study locations

1 site
  • Walkerton
    Walkerton, Ontario N0G 2V0, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00235326
Lead sponsor
McMaster University
First posted
Oct 10, 2005
Start date
Jan 2002
Primary completion
Aug 2008
Completion
Aug 2008
Results posted
Apr 22, 2009
Last update
Apr 22, 2009

Study contacts

John k Marshall, MD, MSc
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion