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Post-Infectious Irritable Bowel Syndrome (PI-IBS) (PI-IBS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01497847
First received: December 16, 2011
Last updated: April 25, 2013
Last verified: April 2013
December 16, 2011
April 25, 2013
March 2010
February 2013   (Final data collection date for primary outcome measure)
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode [ Time Frame: 1 year after traveling ]
Same as current
Complete list of historical versions of study NCT01497847 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post-Infectious Irritable Bowel Syndrome (PI-IBS)
Post-Infectious Irritable Bowel Syndrome (PI-IBS)

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, blood plasma, feces, rectal biopsy
Non-Probability Sample
Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.
Irritable Bowel Syndrome With Diarrhea
Not Provided
travelers to tropical destinations
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01497847
S51501
No
Not Provided
Not Provided
Guy Boeckxstaens, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven
Katholieke Universiteit Leuven
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP