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OpenTrials
Completed

NCT Number: NCT01497847

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

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode

    Time frame: 1 year after traveling

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: PI-IBS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2011
Registry last updated
Apr 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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