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

NCT02516683 | Completed DMC

• 1 other identifier: 3-2011-0242
• Study Type: observational
• Target: 229
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shigella Sonnei Infection

Outcome Measures

Primary Outcomes (1)

• Questionnaire survey for bowel symptoms

  up to 10 years after outbreak

Study Arms (2)

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

control cohort

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

Interventions

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.

Shigella sonnei-exposed cohort

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Shigella sonnei infected patients

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Officials

• Young Hoon Youn, MD, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 6, 2015
• Study Start: December 1, 2001
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2015
• Last Updated: August 6, 2015

Record last verified: 2015-08