Skip to content

Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis

Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02808663
Acronym
CALPRO-HAA
Enrollment
6
Registered
2016-06-22
Start date
2015-05-06
Completion date
2017-02-01
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Alcoholic Hepatitis

Brief summary

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.

Detailed 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.

Interventions

BIOLOGICALfecal calprotectin concentration
BIOLOGICALblood collection

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
fecal calprotectin concentrationDay1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026