Irritable Bowel Syndrome With DiarrheaPI-IBSNCT01497847
Post-Infectious Irritable Bowel Syndrome (PI-IBS)
An observational study of Irritable Bowel Syndrome With Diarrhea, run by KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- How many people
- 131 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.
Who may be able to join
- traveling to South-America, Africa, South-East Asia
- 18-70 years
- traveling for 1-10 weeks
Who cannot join
- Chronic diarrhea
- Pregnant
- Colitis Ulcerosa
- Morbus Chrohn
- IBS
- Coeliakie
Show all 11Show fewer
- Gastrointestinal malabsorption
- microscopic colitis
- diverticulitis
- immune deficiency
- use of antibiotics/corticosteroids 2 weeks before travelling
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- Post-Infectious Irritable Bowel Syndrome, PI-IBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| travelers to tropical destinations | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode
Measured: 1 year after traveling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startMar 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Boeckxstaens, KU Leuven
- Investigators
- Guy Boeckxstaens, M.D., Principal investigator, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497847
- Sponsor's protocol ID
- S51501
- Acronym
- PI-IBS
- Status last verified
- Apr 2013
- First submitted
- 16 Dec 2011
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26071133
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Infectious Irritable Bowel Syndrome (PI-IBS)
- ClinicalTrials.gov ID
- NCT01497847
- Acronym / sponsor ID
- PI-IBS / S51501
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- Post-Infectious Irritable Bowel Syndrome, PI-IBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| travelers to tropical destinations | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.
Key inclusion criteria (3 listed)
- traveling to South-America, Africa, South-East Asia
- 18-70 years
- traveling for 1-10 weeks
Key exclusion criteria (11 listed)
- Chronic diarrhea
- Pregnant
- Colitis Ulcerosa
- Morbus Chrohn
- IBS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode
Time frame: 1 year after traveling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Derived from this study: PubMed 26071133Wouters 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Boeckxstaens, M.D. principal investigator
Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome With Diarrhea, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode (time frame: 1 year after traveling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013; AzTrials last refreshed its copy on 31 Oct 2026.