Shigella Sonnei InfectionNCT02516683
The Long Term Clinical Course of Postinfectious Irritable Bowel Syndrome After Shigellosis; A 10 Year Follow up Study
An observational study of Shigella Sonnei Infection, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigella Sonnei Infection
- What is being tested?
- Shigella sonnei infection
- How many people
- 229 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Shigella sonnei infected patients
Who cannot join
- refused to participate in these surveys
- pregnant or had history of abdominal surgery or chronic organic gastrointestinal disorder
About this 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.
Read more
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.
Read the 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.
- Conditions
- Shigella Sonnei Infection
- Being tested
- Shigella sonnei infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shigella sonnei infectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Shigella sonnei infection | |
| control cohort | A control cohort of age and sex-matched, non-infected 105 contemporary hospital employees. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire survey for bowel symptoms
Measured: up to 10 years after outbreak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startDec 2001
- Primary completionDec 2011
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shigella Sonnei InfectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Hoon Youn, MD, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516683
- Sponsor's protocol ID
- 3-2011-0242
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Clinical Course of Postinfectious Irritable Bowel Syndrome After Shigellosis; A 10 Year Follow up Study
- ClinicalTrials.gov ID
- NCT02516683
- Acronym / sponsor ID
- 3-2011-0242
- Conditions
- Shigella Sonnei Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shigella sonnei-exposed cohort | – | Other: Shigella sonnei infectionShigella 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Shigella sonnei infected patients
Key exclusion criteria (2 listed)
- refused to participate in these surveys
- pregnant or had history of abdominal surgery or chronic organic gastrointestinal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shigella sonnei infectionA 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-exposed cohort |
Primary outcome
Questionnaire survey for bowel symptoms
Time frame: up to 10 years after outbreak
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Hoon Youn, MD, PhD principal investigator
Yonsei University
Questions about this trial
What is this clinical trial studying?
An observational study of Shigella Sonnei Infection, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire survey for bowel symptoms (time frame: up to 10 years after outbreak). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.