Post-Infectious Irritable Bowel Syndrome (PI-IBS) (PI-IBS)
April 25, 2013 updated by: Guy Boeckxstaens, KU Leuven
Purpose:
- identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome (PI-IBS) development after an episode of traveler's diarrhea
- identification of systemic (serum) and local (biopsy) changes in infectious and immunological activity during infection and correlation with Irritable Bowel Syndrome (IBS) symptoms, persisting after traveler's diarrhea
Design:
- 4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12 months after traveling
- at each study visit following investigations: blood collection, stool collection, questionnaires, rectal biopsy
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
131
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- University Hospitals Leuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.
Description
Inclusion Criteria:
- traveling to South-America, Africa, South-East Asia
- 18-70 years
- traveling for 1-10 weeks
Exclusion Criteria:
- Chronic diarrhea
- Pregnant
- Colitis Ulcerosa
- Morbus Chrohn
- IBS
- Coeliakie
- Gastrointestinal malabsorption
- microscopic colitis
- diverticulitis
- immune deficiency
- use of antibiotics/corticosteroids 2 weeks before travelling
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
travelers to tropical destinations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode
Time Frame: 1 year after traveling
|
1 year after traveling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
December 22, 2011
First Posted (Estimate)
December 23, 2011
Study Record Updates
Last Update Posted (Estimate)
April 26, 2013
Last Update Submitted That Met QC Criteria
April 25, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S51501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.