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Severe alcoholic hepatitis, defined by a "Maddrey discriminant function" above 32, is associated with significant short-term mortality. In patients with liver disease, studies have shown alterations of intestinal bacterial flora and an increase in intestinal permeability leading to bacterial translocation across the intestinal barrier. The mechanism involved may be an activation of intestinal macrophages with a local release of cytokines like interleukin-8 (IL-8). Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic hepatitis has never been evaluated. The main objective of this study was to determine if the initial level of fecal calprotectin and its variation after 7 days had a predictive value for the outcome of severe alcoholic hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and predictive of infections.
Severe alcoholic hepatitis, defined by a "Maddrey discriminant function" above 32, is associated with significant short-term mortality. In patients with liver disease, studies have shown alterations of intestinal bacterial flora and an increase in intestinal permeability leading to bacterial translocation across the intestinal barrier. The mechanism involved may be an activation of intestinal macrophages with a local release of cytokines like IL-8. Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic hepatitis has never been evaluated. The main objective of this study was to determine if the initial level of fecal calprotectin and its variation after 7 days had a predictive value for the outcome of severe alcoholic hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was correlated with blood concentration of LPS binding protein and predictive of infections.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Chu Reims
France, Reims, France
Start Date
May 6, 2015
Primary Completion Date
February 1, 2017
Completion Date
February 1, 2017
Last Updated
January 8, 2018
6
ACTUAL participants
fecal calprotectin concentration
BIOLOGICAL
blood collection
BIOLOGICAL
Lead Sponsor
CHU de Reims
NCT06155760
NCT04103840
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT01820208