Post-Infectious Irritable Bowel Syndrome (PI-IBS)

NCT ID: NCT01497847

Last Updated: 2013-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Irritable Bowel Syndrome With Diarrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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travelers to tropical destinations

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Guy Boeckxstaens

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guy Boeckxstaens, M.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University Leuven

Locations

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University hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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Wouters MM, Van Wanrooy S, Nguyen A, Dooley J, Aguilera-Lizarraga J, Van Brabant W, Garcia-Perez JE, Van Oudenhove L, Van Ranst M, Verhaegen J, Liston A, Boeckxstaens G. Psychological comorbidity increases the risk for postinfectious IBS partly by enhanced susceptibility to develop infectious gastroenteritis. Gut. 2016 Aug;65(8):1279-88. doi: 10.1136/gutjnl-2015-309460. Epub 2015 Jun 12.

Reference Type DERIVED
PMID: 26071133 (View on PubMed)

Other Identifiers

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S51501

Identifier Type: -

Identifier Source: org_study_id

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