Irritable Bowel Syndrome With Diarrhea Clinical Trial
— PI-IBSOfficial title:
Post-Infectious Irritable Bowel Syndrome (PI-IBS)
Verified date | April 2013 |
Source | Katholieke Universiteit Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Observational |
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
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | University hospitals Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Katholieke Universiteit Leuven |
Belgium,
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 |
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