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

Tracking Information

First Received Date ^ICMJE

December 16, 2011

Last Updated Date

April 25, 2013

Start Date ^ICMJE

March 2010

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01497847 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Post-Infectious Irritable Bowel Syndrome (PI-IBS)

Official Title ^ICMJE

Post-Infectious Irritable Bowel Syndrome (PI-IBS)

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

whole blood, blood plasma, feces, rectal biopsy

Sampling Method

Non-Probability Sample

Study Population

Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.

Condition ^ICMJE

Irritable Bowel Syndrome With Diarrhea

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

travelers to tropical destinations

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

131

Completion Date

February 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01497847

Other Study ID Numbers ^ICMJE

S51501

Has Data Monitoring Committee

Responsible Party

Guy Boeckxstaens, Katholieke Universiteit Leuven

Study Sponsor ^ICMJE

Katholieke Universiteit Leuven

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Guy Boeckxstaens, M.D.

Catholic University Leuven

Information Provided By

Katholieke Universiteit Leuven

Verification Date

April 2013

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

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