Background: Currently, no non-invasive pancreatic function tests are broadly available apart from fecal elastase-1 (El-1) which has limited sensitivity and specificity. We applied the 13C-MTG for measurement of the effects of a monolithic enteric coated enzyme preparation (i.e. single unit, no microgranules) on lipid digestion and absorption. Due to dissociation between gastric emptying of meal nutrients and enzyme supplements, these older preparations are assumed to be virtually ineffective and potential effects can only be shown by sensitive methods. Methods: 20 patients with documented chronic pancreatitis (19 males, 1 female, age: 52±2 yrs, BMI: 23.1±0.7 kg/m2, El-1: 42.1±8.2 μg/g, mean-SEM) were included in 3 study centres. On two study days which were 3-14 days apart and each preceeded by at least 3 days without intake of enzyme supplements, patients received a monolithic enteric-coated pancreatin preparation (40,000 U of lipase) or placebo together with a standardised test meal containing 250 mg of 13C-mixed triglycerides according to a randomised, double blind, cross-over study design. Differences between cumulative 13C-exhalation were evaluated as markers of lipid digestion during treatment with verum and placebo. Results: (mean±SEM, statistics: ANOVA): One patient had to be excluded because of major protocol violations; 6 patients were excluded from the per protocol analysis because of normal intestinal lipolysis during placebo treatment despite decreased El-1. In the remaining 13 patients, mean cumulative 13C-exhalation over 6 and 8 hours was markedly higher following treatment with verum compared to placebo (6 h: 11±2 vs. 5±1% of dose, p = 0.035; 8 h: 18±3 vs. 9±1% of dose, p = 0.015). Conclusions: In contrast to current belief, single administration of a monolithic enteric-coated pancreatin preparation containing 40,000 U of lipase significantly improves lipid digestion and absorption compared to placebo in patients with severe pancreatic exocrine insufficiency. Sensitivity of the 13C-MTG allows detection of these effects and, thus, this non-invasive test may expand our diagnostic armamentarium in pancreatic exocrine insufficiency.
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