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OpenTrials
Completed

NCT Number: NCT02516683

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

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.

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Key information

Conditions

Shigella Sonnei Infection

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shigella sonnei infection

Other

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.

Primary outcomes

  1. Questionnaire survey for bowel symptoms

    Time frame: up to 10 years after outbreak

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2001
Primary completion
2011
Study completion
2015
First posted
Aug 6, 2015
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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