ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01497847
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven

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

Condition or disease
Irritable Bowel Syndrome With Diarrhea

Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Infectious Irritable Bowel Syndrome (PI-IBS)
Study Start Date : March 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Group/Cohort
travelers to tropical destinations



Primary Outcome Measures :
  1. postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode [ Time Frame: 1 year after traveling ]

Biospecimen Retention:   Samples With DNA
whole blood, blood plasma, feces, rectal biopsy


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497847


Locations
Belgium
University hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guy Boeckxstaens, Principal Investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01497847     History of Changes
Other Study ID Numbers: S51501
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Guy Boeckxstaens, Katholieke Universiteit Leuven:
Post-Infectious Irritable Bowel Syndrome
PI-IBS

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Communicable Diseases
Infection
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases