Performance of 13C Mannitol for in Vivo Measurement of Small Intestinal Permeability
Completed · Phase 1
Conditions studied: Impaired Small Intestinal Permeability
In brief
The investigators' overall objective with this study is to determine performance characteristics of small intestine permeability measurement using 13C mannitol and 12C (regular) mannitol.
Key facts
- Study ID
- NCT02603822
- Run by
- Mayo Clinic
- People needed
- 25
- Starts
- 2015-08-01
- Expected to finish
- 2018-07-17
- Last updated by the study team
- 2019-06-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age (yr) 18 to 65
- No abdominal surgery (except appendectomy and cholecystectomy, others may be considered)
You may not qualify if…
- History of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease.
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin within seven days of first permeability test (as NSAIDs affect intestinal permeability) and second permeability test (except those administered for the study)
- Use of oral corticosteroids within the previous 6 weeks
- Ingestion of artificial sweeteners such as Splenda® (sucralose), NutraSweet® (aspartame), lactulose or mannitol within two (2) days of each permeability test and endoscopy procedure date, 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 within 7 days each permeability test and endoscopy procedure date. This includes drugs such as serotonin (5-HT) agents, narcotics, anticholinergics, anti-nausea medications, any medications for diarrhea or constipation.
- Antibiotics within 7 days each permeability test and endoscopy procedure date
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- Score > 8 for anxiety or depression on Hospital Anxiety and Depression scale.
- Pregnancy
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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