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NCT01497847 Clinical Trial

Post-Infectious Irritable Bowel Syndrome (PI-IBS)

Irritable Bowel Syndrome With Diarrhea Clinical Trial

— PI-IBS  

Official title:
Post-Infectious Irritable Bowel Syndrome (PI-IBS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01497847
Other study ID # S51501
Secondary ID
Status Completed
Phase N/A
First received December 16, 2011
Last updated April 25, 2013
Start date March 2010
Est. completion date February 2013

Study information
Verified date April 2013
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical 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 (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

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium University hospitals Leuven Leuven Vlaams-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode 1 year after traveling No
See also
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Withdrawn NCT02320318 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
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Enrolling by invitation NCT05311293 - Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
Completed NCT05277428 - Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1 N/A
Not yet recruiting NCT03221790 - Effect of FODMAPs on Mucosal Inflammation in IBS Patients N/A
Completed NCT03557788 - Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome Phase 4
Completed NCT02757105 - Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) Phase 2
Recruiting NCT04830410 - The Effects of Carbohydrates in Irritable Bowel Syndrome N/A
Completed NCT03245645 - FODMAP Reintroduction in Irritable Bowel Syndrome N/A
Completed NCT02107196 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Terminated NCT02120027 - 52-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3