Shigella Sonnei Infection Clinical Trial
Official title:
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.
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.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02676895 -
A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults
|
Phase 2 |