Post-Infectious Irritable Bowel Syndrome (PI-IBS)
PI-IBS
1 other identifier
observational
131
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedApril 26, 2013
April 1, 2013
2.9 years
December 16, 2011
April 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode
1 year after traveling
Study Arms (1)
travelers to tropical destinations
Eligibility Criteria
Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.
You may qualify if:
- traveling to South-America, Africa, South-East Asia
- years
- traveling for 1-10 weeks
You may not qualify if:
- Chronic diarrhea
- Pregnant
- Colitis Ulcerosa
- Morbus Chrohn
- IBS
- Coeliakie
- Gastrointestinal malabsorption
- microscopic colitis
- diverticulitis
- immune deficiency
- use of antibiotics/corticosteroids 2 weeks before travelling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
University hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Related Publications (1)
Wouters MM, Van Wanrooy S, Nguyen A, Dooley J, Aguilera-Lizarraga J, Van Brabant W, Garcia-Perez JE, Van Oudenhove L, Van Ranst M, Verhaegen J, Liston A, Boeckxstaens G. Psychological comorbidity increases the risk for postinfectious IBS partly by enhanced susceptibility to develop infectious gastroenteritis. Gut. 2016 Aug;65(8):1279-88. doi: 10.1136/gutjnl-2015-309460. Epub 2015 Jun 12.
PMID: 26071133DERIVED
Biospecimen
whole blood, blood plasma, feces, rectal biopsy
Study Officials
- PRINCIPAL INVESTIGATOR
Guy Boeckxstaens, M.D.
Catholic University Leuven
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 16, 2011
First Posted
December 23, 2011
Study Start
March 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
April 26, 2013
Record last verified: 2013-04