Trial Outcomes & Findings for Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario (NCT NCT00235326)

Last Updated: 2009-04-22

Results Overview

Recruitment status

COMPLETED

Target enrollment

4561 participants

Primary outcome timeframe

8 years

Results posted on

2009-04-22

Residents of Walkerton in may 2000

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

Participant milestones
Measure	Unexposed to Gastroenteritis	Exposed to Gastroenteritis
Overall Study STARTED	1575	2986
Overall Study COMPLETED	829	1586
Overall Study NOT COMPLETED	746	1400

Reasons for withdrawal
Measure	Unexposed to Gastroenteritis	Exposed to Gastroenteritis
Overall Study Lost to Follow-up	746	1400

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

Baseline characteristics by cohort
Measure	Unexposed to Gastroenteritis n=1575 Participants	Exposed to Gastroenteritis n=2986 Participants	Total n=4561 Participants Total of all reporting groups
Age, Categorical <=18 years	471 Participants n=93 Participants	907 Participants n=4 Participants	1378.0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	905 Participants n=93 Participants	1810 Participants n=4 Participants	2715.0 Participants n=27 Participants
Age, Categorical >=65 years	199 Participants n=93 Participants	269 Participants n=4 Participants	468.0 Participants n=27 Participants
Age Continuous	36.96 years STANDARD_DEVIATION 22.76 • n=93 Participants	34.97 years STANDARD_DEVIATION 21.61 • n=4 Participants	35.66 years STANDARD_DEVIATION 22.03 • n=27 Participants
Sex: Female, Male Female	892 Participants n=93 Participants	1665 Participants n=4 Participants	2557.0 Participants n=27 Participants
Sex: Female, Male Male	683 Participants n=93 Participants	1321 Participants n=4 Participants	2004.0 Participants n=27 Participants
Region of Enrollment Canada	1575 participants n=93 Participants	2986 participants n=4 Participants	4561.0 participants n=27 Participants

Timeframe: 8 years

Outcome measures
Measure	Unexposed to Gastroenteritis n=829 Participants	Exposed to Gastroenteritis n=1586 Participants
Number of Participants With Post Infectious Irritable Bowel Syndrome	23 participants	114 participants

Adverse event data not reported

Adverse event data not reported

McMaster University

Phone: 9055212100

Restriction type: LTE60