Gut Permeability, Sensitivity and Symptomatology
Completed · Not applicable
Conditions studied: Irritable Bowel Syndrome, Visceral Hypersensitivity
In brief
To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS).
Key facts
- Study ID
- NCT02358564
- Run by
- Mayo Clinic
- People needed
- 39
- Starts
- 2015-02-01
- Expected to finish
- 2021-03-11
- Last updated by the study team
- 2021-09-05
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18 to 70 years
- No abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and C-section).
- Written informed consent
You may not qualify if…
- Females who are pregnant or breastfeeding
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
- Use of oral corticosteroids within the previous 6 weeks
- Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
- Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins.
- Proton pump inhibitors.
- Antibiotics for the preceding 60 days before the start of the study.
- (vii) Alcohol intake beyond the recommended safe limit (<21 unites per week)
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- Known allergy to fluorescein
- Inflammatory bowel diseases, celiac disease.
Where it is running
- Mayo Clinic in Florida — Jacksonville, Florida, United States
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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