NCT00235326

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,561

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 22, 2009

Completed
Last Updated

April 22, 2009

Status Verified

March 1, 2009

Enrollment Period

6.6 years

First QC Date

October 6, 2005

Results QC Date

February 5, 2009

Last Update Submit

March 16, 2009

Conditions

Irritable Bowel Syndrome

Keywords

residents of Walkerton ontario at outbreak

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Post Infectious Irritable Bowel Syndrome

    8 years

Study Arms (2)

2

Unexposed to gastroenteritis

1

Exposed to gastroenteritis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents of walkerton

You may qualify if:

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

You may not qualify if:

  • Non residents of Walkerton Ontario at the time of outbreak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walkerton

Walkerton, Ontario, N0G 2V0, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
John Marshall
Organization
McMaster University
marshllj@mcmaster.ca
9055212100

Study Officials

  • John k Marshall, MD, MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

January 1, 2002

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 22, 2009

Results First Posted

April 22, 2009

Record last verified: 2009-03

Locations

CA(1)