Quantitative Fecal Lactoferrin as a Biomarker for Severe Clostridium difficile Infection in Hospitalized Patients.

BACKGROUND: The incidence and severity of Clostridium difficile infection (CDI) have increased over the past decade, especially among hospitalized patients. In this study, we determined the value of published criteria for severe CDI in predicting 3 month mortality, as well as the utility of fecal lactoferrin as a biomarker for severe CDI. METHODS: Pilot Year 1 of IRB approved (HSR-IRB# 13630) prospective cohort study of hospitalized patients with CDI at US academic medical center (10/08-4/10). Medical records of hospitalized patients with clinically diagnosed CDI, via toxin assay, were evaluated to objectively define severe CDI based on current guidelines. A stool sample from CDI diagnosis was analyzed for amount of fecal lactoferrin (IBD-SCAN, TechLab, Inc.). Data was analyzed using SPSS for student's t-test and chi-squared, significance p ≤ 0.05. RESULTS: 79 subjects consented and enrolled, mean age was 64 years (standard deviation, sd, 17.2), 48 (61%) female, and average Charlson co-morbidity score was 5.8 (sd 3.8). Subjects with severe CDI were 5 times more likely to die within 3 months of diagnosis (Odds Ratio 5.66 (95% Confidence Interval 2.03-15.79), p=0.001) and had significantly more fecal lactoferrin (580.0 (sd 989.0) vs. 181.7 (sd 244.2) µg/mL, p=0.018), compared to those that did not meet severe CDI criteria. CONCLUSION: In this pilot study, subjects who meet defined criteria for severe CDI had higher mortality and more intestinal inflammation. These preliminary results were, however, underpowered to show a direct association of lactoferrin with mortality. Larger cohort studies are needed to optimize a criterion for severe CDI and evaluate a direct association of lactoferrin and mortality in hospitalized patients with CDI.