Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders (NCT03266068) | Clinical Trial Compass
CompletedNot Applicable
Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
United States120 participantsStarted 2016-09
Plain-language summary
Some people develop chronic abdominal pain with diarrhea or constipation after an episode of acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact reason why certain individuals develop these symptoms whereas others don't is not exactly clear.
The researchers are studying changes in gastrointestinal permeability (movement of contents across the lining of the intestine) and transit (movement of food through the gastrointestinal tract). The researchers are also studying if there are any genetic risk factors that are associated with development of this disorder.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. IBS by Rome III criteria
✓. No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)
✓. No IBS by Rome III criteria
✓. No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)
Exclusion criteria
✕. Prior history of IBS or inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease
✕. Ingestion of artificial sweeteners such as sucralose, aspartame, lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda
✕. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins
✕. Any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron
. Drugs with a known pharmacological activity at serotonin type 4 (5-HT4), serotonin receptor 2B (5-HT2b) or 5-HT3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine)
✕. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)