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

NCT02808663 | Completed

• 1 other identifier: PA14069
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (2)

• fecal calprotectin concentration

  Day1

• fecal calprotectin concentration

  Day7

Study Arms (1)

Severe Alcoholic Hepatitis

EXPERIMENTAL

Biological: fecal calprotectin concentration; Biological: blood collection

Interventions

fecal calprotectin concentration BIOLOGICAL

Severe Alcoholic Hepatitis

blood collection BIOLOGICAL

Severe Alcoholic Hepatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age below 18
• pregnant or breastfeeding women
• history of intestinal disease, digestive haemorrhage
• patient under guardianship

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

France, Reims, 51092, France

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 22, 2016
• Study Start: May 6, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

FR (1)