Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis (CALPRO-HAA)
Primary Purpose
Severe Alcoholic Hepatitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fecal calprotectin concentration
blood collection
Sponsored by
About this trial
This is an interventional other trial for Severe Alcoholic Hepatitis
Eligibility Criteria
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
Sites / Locations
- Chu Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Severe Alcoholic Hepatitis
Arm Description
Outcomes
Primary Outcome Measures
fecal calprotectin concentration
fecal calprotectin concentration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02808663
Brief Title
Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis
Acronym
CALPRO-HAA
Official Title
Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 6, 2015 (undefined)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Alcoholic Hepatitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Severe Alcoholic Hepatitis
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
fecal calprotectin concentration
Intervention Type
Biological
Intervention Name(s)
blood collection
Primary Outcome Measure Information:
Title
fecal calprotectin concentration
Time Frame
Day1
Title
fecal calprotectin concentration
Time Frame
Day7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Reims
City
France
State/Province
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis
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