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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235326
First Posted: October 10, 2005
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McMaster University
Results First Submitted: February 5, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Irritable Bowel Syndrome

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Residents of Walkerton in may 2000

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Age less than 16, non-residents of walkerton, premorbid Inflammatory Bowel disease(IBD) /Irritable bowel syndrome(IBS)

Reporting Groups
  Description
Unexposed to Gastroenteritis No text entered.
Exposed to Gastroenteritis No text entered.

Participant Flow:   Overall Study
    Unexposed to Gastroenteritis   Exposed to Gastroenteritis
STARTED   1575   2986 
COMPLETED   829   1586 
NOT COMPLETED   746   1400 
Lost to Follow-up                746                1400 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Unexposed to Gastroenteritis No text entered.
Exposed to Gastroenteritis No text entered.
Total Total of all reporting groups

Baseline Measures
   Unexposed to Gastroenteritis   Exposed to Gastroenteritis   Total 
Overall Participants Analyzed 
[Units: Participants]
 1575   2986   4561 
Age 
[Units: Participants]
     
<=18 years   471   907   1378 
Between 18 and 65 years   905   1810   2715 
>=65 years   199   269   468 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.96  (22.76)   34.97  (21.61)   35.66  (22.03) 
Gender 
[Units: Participants]
     
Female   892   1665   2557 
Male   683   1321   2004 
Region of Enrollment 
[Units: Participants]
     
Canada   1575   2986   4561 


  Outcome Measures

1.  Primary:   Number of Participants With Post Infectious Irritable Bowel Syndrome   [ Time Frame: 8 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Marshall
Organization: McMaster University
phone: 9055212100 ext 76782
e-mail: marshllj@mcmaster.ca



Responsible Party: John Marshall, Mcmaster University
ClinicalTrials.gov Identifier: NCT00235326     History of Changes
Other Study ID Numbers: 02-026; 05-346
First Submitted: October 6, 2005
First Posted: October 10, 2005
Results First Submitted: February 5, 2009
Results First Posted: April 22, 2009
Last Update Posted: July 29, 2009