Fecal lactoferrin as a biomarker for determining disease severity and for treating infection in patients with
Clostridium difficile disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases of C. difficile are treated differently depending on severity of disease. Mild and moderate cases may be treated with metronidazole while moderate-to-severe and relapsing cases are often treated with vancomycin or fidaxomicin. The presence of C. difficile disease is detected using a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected of C. difficile disease, if GDH is detected indicating the presence of C. difficile , and then toxins A and/or B are detected to indicate toxigenic C. difficile and support a diagnosis of C. difficile -associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.
1. A method of treating a patient with a C. difficile infection, the method comprising:
quantitatively measuring a level of lactoferrin in a fecal sample from a patient with a C. difficile infection;
determining that the patient has moderate-to-severe C. difficile disease based on the measured level of lactoferrin in the fecal sample being equal to or greater than 100 μg/mL; and
subsequent to the determining that the patient has moderate-to severe C. difficile disease, administering a therapeutically effective treatment, the therapeutically effective treatment comprising a native flora transplant.
2. The method of claim 1 , wherein the level of lactoferrin in the fecal sample is determined via a quantitative enzyme immunoassay (EIA).
3. The method of claim 1 , further comprising: subsequent to administering the therapeutically effective treatment for C. difficile disease, determining a presence of one or more biomarkers to indicate the presence or absence of C. difficile bacteria in the patient.
4. The method of claim 3 , wherein the one or more biomarkers comprises C. difficile toxin A or C. difficile toxin B.
5. A method of treating a patient with C. difficile disease, the method comprising:
obtaining a fecal sample from a patient having been diagnosed with C. difficile disease;
measuring the fecal sample for a level of lactoferrin; and
determining that the patient has moderate-to-severe disease based on the measured fecal sample having a level of lactoferrin equal to or greater than 100 μg/mL; and
subsequent to the determining that the patient has moderate-to severe C. difficile disease, administering a therapeutically effective treatment comprising a native flora transplant.
6. The method of claim 5 , wherein the level of lactoferrin in the fecal sample is determined via a quantitative enzyme immunoassay (EIA).
7. The method of claim 5 , wherein the determining the patient has moderate-to-severe C. difficile disease is further based on one or more of:
clinical indicators of the patient, the clinical indicators comprising one or more of a number of unformed stools per day, a presence of fever, abdominal pain, and vomiting; and
lab tests of the patient, the lab tests comprising one or more tests for C-reactive protein (CRP), white blood cell count (WBC), serum albumin, and creatinine.
8. The method of claim 5 , wherein the patient having been diagnosed with C. difficile disease was diagnosed at least partly by detecting a presence of a biomarker that indicates a presence of toxigenic C. difficile.