The Effect of Gut Sterilisation on Macrophage Activation in Patients With Alcoholic Hepatitis.

NCT03157388 | Completed

• 1 other identifier: 1-10-72-1-15
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Alcoholic hepatitis (AH) is a severe alcohol induced hepatic inflammation that leads to jaundice and liver failure. Gut derived bacterial translocation to the liver is currently thought to be one of the main inflammatory drivers of the disease. This project investigates the effects of gut sterilisation with broad spectrum antibiotics in patients with AH

Conditions

Alcoholic Hepatitis

Keywords

inflammation; Macrophages; CD163

Outcome Measures

Primary Outcomes (1)

• Macrophage activation cd163

  Difference in serum levels of macrophage activation markers sCD163

  1 year

Secondary Outcomes (3)

• LBP

  1 year

• TNF alfa

  1 year

• Interleukin-1b

  1 year

Study Arms (1)

Intervention

EXPERIMENTAL

Combined Vancomycin and Gentamycin and Meropenem

Drug: Combined Vancomycin and Gentamycin and Meropenem

Interventions

Combined Vancomycin and Gentamycin and Meropenem DRUG

The following combined antibiotic regime will be administered for eradication of gut bacteria. 7 days combined antibiotic treatment, per oral route, once daily: vancomycin 500 mg (Vancomycin "Hospira"), powder for concentrate and gentamycin 40 mg ("Hexamycin®"), solution and meropenem 500 mg (Meropenem "Hospira"), powder for concentrate; The three drugs are dissolved and combined in approximately 100 ml of apple juice.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A first time diagnose of AH by a combination of physical and laboratory criteria:
• A history of excessive alcohol ingestion (10 units or more per day) until at least three weeks before admission
• Acute jaundice (developed over at most 2 weeks, serum bilirubin \> 80 μmol/l).
• liverbiopsy will be performed in case of doubt regarding the diagnosis.

You may not qualify if:

• Non-native speaking Danish
• Viral hepatitis,
• Autoimmune liver disease,
• Bile duct obstruction,
• Liver tumours or any other cancer,
• Presence of an infectious focus (either clinically assessed or based on chest x-ray, urine samples or ascites puncture),
• On-going gastrointestinal bleeding or bleeding within the previous three months
• Any prior immune-modulating therapy.
• Any known gastrointestinal disease
• Contraindications against/allergy towards the used antibiotics

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic; Inflammation

Interventions

Gentamicins; Meropenem

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hendrik D Vilstrup, Professor

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

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

Model Details: 15 patients with alcoholic hepatitis will be consecutively included and compared to a historical cohort of AH patients

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 23, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)