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Post-Infectious Irritable Bowel Syndrome (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
History of Changes
  Purpose

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
Irritable Bowel Syndrome With Diarrhea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Infectious Irritable Bowel Syndrome (PI-IBS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode [ Time Frame: 1 year after traveling ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, blood plasma, feces, rectal biopsy


Enrollment: 131
Study Start Date: March 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
travelers to tropical destinations

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Guy Boeckxstaens, Principal Investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01497847     History of Changes
Other Study ID Numbers: S51501
Study First Received: December 16, 2011
Last Updated: April 25, 2013
Health Authority: Belgium: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013