Irritable Bowel SyndromeNCT00235326
Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario
An observational study of Irritable Bowel Syndrome, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 4,561 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2002to Aug 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: residents of walkerton
Who may be able to join
- Participants must be residents of the Walkerton, Ontario region at the time of Outbreak who consented to the study
Who cannot join
- Non residents of Walkerton Ontario at the time of outbreak
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Irritable Bowel Syndrome
- Keywords
- residents of Walkerton ontario at outbreak
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Unexposed to gastroenteritis | |
| 1 | Exposed to gastroenteritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Post Infectious Irritable Bowel Syndrome
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startJan 2002
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Investigators
- John k Marshall, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235326
- Sponsor's protocol ID
- 02-026; 05-346
- Status last verified
- Mar 2009
- First submitted
- 6 Oct 2005
- Last updated
- 22 Apr 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario
- ClinicalTrials.gov ID
- NCT00235326
- Acronym / sponsor ID
- 02-026; 05-346
- Conditions
- Irritable Bowel Syndrome
- Keywords
- residents of Walkerton ontario at outbreak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,561 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Posted 22 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –Unexposed to gastroenteritis |
| 1 | – | –Exposed to gastroenteritis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- residents of walkerton
Key inclusion criteria (1 listed)
- Participants must be residents of the Walkerton, Ontario region at the time of Outbreak who consented to the study
Key exclusion criteria (1 listed)
- Non residents of Walkerton Ontario at the time of outbreak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Post Infectious Irritable Bowel Syndrome
Time frame: 8 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John k Marshall, MD, MSc principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Post Infectious Irritable Bowel Syndrome (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2009.