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.

Study Overview

• Status: Completed
• Conditions: Shigella Sonnei Infection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 229

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Questionnaire survey for bowel symptoms	up to 10 years after outbreak

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Young Hoon Youn, MD, PhD, Yonsei University

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Dysentery; Irritable Bowel Syndrome; Dysentery, Bacillary
• Other Study ID Numbers: 3-2011-0242