Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis (CALPRO-HAA)

CHU de Reims

Status: Completed

Conditions: Severe Alcoholic Hepatitis

Treatments: Biological: blood collection; Biological: fecal calprotectin concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT02808663

PA14069

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with severe alcoholic hepatitis defined by a "Maddrey discriminant function" above 32
• histological confirmation of the diagnosis and indication for corticotherapy
• signed written informed consent and social security affiliation

Exclusion criteria

• age below 18
• pregnant or breastfeeding women
• history of intestinal disease, digestive haemorrhage
• treatment with antibiotics, NSAIDs or proton pump inhibitors during the month before inclusion
• patient under guardianship

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Severe Alcoholic Hepatitis

Experimental group

Treatment:

Biological: fecal calprotectin concentration

Biological: blood collection