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The Long Term Clinical Course of Postinfectious Irritable Bowel Syndrome After Shigellosis; A 10 Year Follow up Study

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ClinicalTrials.gov Identifier: NCT02516683
Recruitment Status : Completed
First Posted : August 6, 2015
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Background: The incidence of postinfectious irritable bowel syndrome (PI-IBS) was reported to be in the range of 5-30%, but limited number of long-term follow-up results.

Objective: To investigate the long term clinical course of PI-IBS after Shigellosis.

Setting: A Shigellosis outbreak in a tertiary referral hospital with about 2,000 employees in Korea at 2001.

Patients: A Shigella-exposed cohort of 124 hospital employees who had been infected by Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance Hospital, Seoul, Korea, at December 2001. A control cohort of age and sex-matched, non-infected 105 contemporary hospital employees.

Measurements: Questionnaire survey for bowel symptoms at 1, 3, 5, 8 and 10 years after outbreak.


Condition or disease Intervention/treatment
Shigella Sonnei Infection Other: Shigella sonnei infection

Detailed Description:

Postinfectious-IBS (PI-IBS) can be defined as the acute onset of new IBS symptoms in an individual, who has not previously met the criteria for IBS, immediately following an acute illness characterized by 2 or more of the following: fever, vomiting, diarrhea, or a positive bacterial stool culture.

Our group previously have reported clinical course of PI-IBS in a homogenous cohort which was comprised of patients recovered from Shigellosis. And in current study, we finally report a collective result of 10-year long-term follow-up of our small, but well-followed, homogenous cohort of PI-IBS after Shigellosis.


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Study Type : Observational
Actual Enrollment : 229 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Long Term Clinical Course of Postinfectious Irritable Bowel Syndrome After Shigellosis; A 10 Year Follow up Study
Study Start Date : December 2001
Actual Primary Completion Date : December 2011
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Shigella sonnei-exposed cohort
Shigella sonnei infection - A Shigella-exposed cohort of 124 hospital employees who had been infected by Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance Hospital, Seoul, Korea, at December 2001.
Other: Shigella sonnei infection
A Shigella-exposed cohort of 124 hospital employees who had been infected by Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance Hospital, Seoul, Korea, at December 2001.

control cohort
A control cohort of age and sex-matched, non-infected 105 contemporary hospital employees.



Primary Outcome Measures :
  1. Questionnaire survey for bowel symptoms [ Time Frame: up to 10 years after outbreak ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
a Shigellosis outbreak took place at Gangnam Severance Hospital in Seoul, Korea, due to the consumption of contaminated food in the hospital cafeteria for employees. The causative pathogen was Shigella sonnei, and a total of 181 patients were diagnosed and treated for Shigellosis. After the termination of Shigellosis outbreak, we could establish a cohort of the Shigella-exposed group for serial surveys. The initially established Shigella-exposed cohort was comprised of 143 subjects, and we also could recruited the control group as age- and sex-matched healthy volunteers who were also hospital employees at same period and had not been infected, nor exposed to causal food.
Criteria

Inclusion Criteria:

  • Shigella sonnei infected patients

Exclusion Criteria:

  • refused to participate in these surveys
  • pregnant or had history of abdominal surgery or chronic organic gastrointestinal disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516683


Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Young Hoon Youn, MD, PhD Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02516683     History of Changes
Other Study ID Numbers: 3-2011-0242
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Dysentery, Bacillary
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dysentery
Gastroenteritis