Crobach MJ, Dekkers OM, Wilcox MH, Kuijper EJ European Society of Clinical Microbiology and Infectious Diseases (ESCMID): data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009 Dec;15(12):1053-66. doi: 10.1111/j.1469-0691.2009.03098.x. Review.
Menees SB, Powell C, Kurlander J, Goel A, Chey WD A meta-analysis of the utility of C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS. Am J Gastroenterol. 2015 Mar;110(3):444-54. doi: 10.1038/ajg.2015.6. Epub 2015 Mar 3. Review.
Mosli MH, Zou G, Garg SK, Feagan SG, MacDonald JK, Chande N, Sandborn WJ, Feagan BG C-Reactive Protein, Fecal Calprotectin, and Stool Lactoferrin for Detection of Endoscopic Activity in Symptomatic Inflammatory Bowel Disease Patients: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2015 Jun;110(6):802-19; quiz 820. doi: 10.1038/ajg.2015.120. Epub 2015 May 12. Review.
Pawlowski SW, Warren CA, Guerrant R Diagnosis and treatment of acute or persistent diarrhea. Gastroenterology. 2009 May;136(6):1874-86. doi: 10.1053/j.gastro.2009.02.072. Epub 2009 May 7. Review.
Peretz A, Tkhawkho L, Pastukh N, Brodsky D, Halevi CN, Nitzan O Correlation between fecal calprotectin levels, disease severity and the hypervirulent ribotype 027 strain in patients with Clostridium difficile infection. BMC Infect Dis. 2016 Jun 22;16:309. doi: 10.1186/s12879-016-1618-8.
Popiel KY, Gheorghe R, Eastmond J, Miller MA Usefulness of Adjunctive Fecal Calprotectin and Serum Procalcitonin in Individuals Positive for Clostridium difficile Toxin Gene by PCR Assay. J Clin Microbiol. 2015 Nov;53(11):3667-9. doi: 10.1128/JCM.02230-15. Epub 2015 Sep 9.
Reintam Blaser A, Deane AM, Fruhwald S Diarrhoea in the critically ill. Curr Opin Crit Care. 2015 Apr;21(2):142-53. doi: 10.1097/MCC.0000000000000188. Review.
van Rheenen PF, Van de Vijver E, Fidler V Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010 Jul 15;341:c3369. doi: 10.1136/bmj.c3369. Review.
Whitehead SJ, Shipman KE, Cooper M, Ford C, Gama R Is there any value in measuring faecal calprotectin in Clostridium difficile positive faecal samples? J Med Microbiol. 2014 Apr;63(Pt 4):590-593. doi: 10.1099/jmm.0.067389-0. Epub 2014 Jan 25.
Fecal Calprotectin Level in Differentiating Between Inflammatory and Non-inflammatory Diarrhea in Patients With Nosocomial Diarrhea
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
