Status:
COMPLETED
Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Campylobacter Infections
Irritable Bowel Syndrome
Eligibility:
All Genders
18-80 years
Brief 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 synd...
Detailed Description
The Centers for Disease Control and prevention (CDC) estimates that each year roughly 1 in 6 Americans (or 48 million people) contact food-borne illnesses. The CDC also estimates that between 20 and 4...
Eligibility Criteria
Inclusion
- Post Infectious IBS Cases
- IBS by Rome III criteria
- No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)
- Post Infectious with no IBS Controls
- No IBS by Rome III criteria
- No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)
- Post Infectious IBS Cases and Post Infectious with no IBS Controls
Exclusion
- 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)
- Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline)
- Ultram
- GI preparations
- Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine)
- Osmotic laxative agents (e.g, lactulose, sorbitol or polyethylene glycol (PEG) solutions as Miralax and Glycolax)
- Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone)
- Antimuscarinics
- Peppermint oil
- Systemic antibiotics, rifaximin, metronidazole
- Any females who are pregnant or trying to become pregnant (due to radiation exposure)
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies
- Healthy Control Inclusion Criteria:
- No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)
- No history of acute gastroenteritis, food-poisoning or travel related diarrhea within last 2 years.
- Healthy Control
Key Trial Info
Start Date :
September 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03266068
Start Date
September 1 2016
End Date
March 11 2020
Last Update
January 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905