The investigators' overall objective with this study is to determine performance characteristics of small intestine permeability measurement using 13C mannitol and 12C (regular) mannitol.
An impaired intestinal permeability is implicated in the pathophysiology of a number of disorders such as celiac disease, environmental enteropathy, inflammatory bowel disease, obesity, and HIV. Current measurements of intestinal permeability rely on urinary excretion of naturally available, orally ingested, non-absorbable sugars (e.g. lactulose, mannitol). However, dietary intake of these sugars limits interpretation from these assays. Subjects will have an esophagogastroduodenoscopy (EGD) with biopsies and provide a baseline urine sample. They will be asked to ingest 3 saccharides (12C mannitol 100 mg,13C mannitol 100 mg and lactulose 1 g) in 250 ml of water. Urine samples will be obtained every 30 min. in the Clinical Research and Trials Unit (CRTU) for 0-2 hours. Subjects will collect 2-8 hour sample in provided container. Another container will be provided to collect the 8-24 hour urine which will be returned the following morning. Subjects will undergo an Indomethacin challenge intervention. They will be instructed to take three 25 mg capsules 8 hours before their next visit (just before fasting). They will take 3 additional 25 mg capsules 30 min. before the repeat in vivo permeability testing. Repeat EGD with duodenal biopsies will be done. Long term follow-up will be done within 4-6 weeks of previous testing, where subjects will once again be asked to complete the in vivo permeability testing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
25
12C mannitol 100 mg
Subjects will receive six 25 mg capsules of Indomethacin (immediate release). The subjects will take 3 capsules 8 hours before the timing of visit 5 (before fasting), and 3 additional capsules 30 minutes before visit 5.
13C mannitol 100 mg
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Small intestine permeability as measured by change in cumulative excretion of mannitol 0-2 hours
Time frame: baseline, approximately 2 hours
Colonic permeability as measured by change in mannitol excretion between 8 and 24 hours
Time frame: 8 hours, approximately 24 hours
Change in mannitol excretion at 24 hours
Time frame: baseline, approximately 24 hours
Change in lactulose-mannitol excretion assay at 2 hours
The ratio of urinary excretion of lactulose to mannitol was used to measure intestinal mucosal permeability, with higher ratios indicative of increased intestinal permeability.
Time frame: baseline, approximately 2 hours
Change in hour lactulose-mannitol excretion assay between 8 and 24 hours
The ratio of urinary excretion of lactulose to mannitol was used to measure intestinal mucosal permeability, with higher ratios indicative of increased intestinal permeability.
Time frame: 8 hours, approximately 24 hours
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lactulose 1 g