Post-Infectious Irritable Bowel Syndrome (PI-IBS)

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea

• Registration Number: NCT01497847
• Lead Sponsor: KU 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode	1 year after traveling

Trial Locations

Locations (1)

University hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium