Post-Infectious Irritable Bowel Syndrome (PI-IBS) | NCT01497847

Studies
Post-Infectious Irritable Bowel Syndrome (PI-IBS)

NCT01497847

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Apr 26, 2013Estimated

Enrollment

131Actual

Phase

Not provided

Conditions

Irritable Bowel Syndrome With Diarrhea

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Dec 16, 2011

First Submission Date that Met QC Criteria

Dec 22, 2011

First Posted Date

Dec 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2013

Last Update Posted Date

Apr 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

131Actual

Label	Type	Description	Intervention Names
travelers to tropical destinations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode		1 year after traveling

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guy Boeckxstaens, M.D.	Catholic University Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospitals Leuven		Leuven	Vlaams-Brabant	3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26071133	Derived	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.