Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-09

Study Completion Date

2024-12-01

Brief Summary

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To investigate the effects of acute alcohol challenge on the gut and liver axis.

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Detailed Description

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To study the role of acute alcohol challenge on the intestine permeability and inflow of bacterial products to the liver in participants with alcoholic liver disease, non-alcoholic steatohepatitis and healthy controls.

Conditions

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Liver Fibroses Alcohol-Induced Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alcoholic liver fibrosis

Group Type ACTIVE_COMPARATOR

Ethanol

Intervention Type OTHER

1 milliliter per kilogram body weight adjusted for elevated body mass index

Non-alcoholic steatohepatitis

Group Type ACTIVE_COMPARATOR

Ethanol

Intervention Type OTHER

1 milliliter per kilogram body weight adjusted for elevated body mass index

Healthy control

Group Type ACTIVE_COMPARATOR

Ethanol

Intervention Type OTHER

1 milliliter per kilogram body weight adjusted for elevated body mass index

Interventions

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Ethanol

1 milliliter per kilogram body weight adjusted for elevated body mass index

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals

And all of following:

* Bodymass \> 50 kg
* Able to be fasting and abstinent on the day of intervention
* international ratio \<1.5 and platelets \>100 x 10\^9, 7 days before the intervention day
* Informed consent

Exclusion Criteria

* Antibiotics during the last 4 weeks
* Total alcohol abstinence
* Desire of total alcohol abstinence
* Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons diseases, alfa 1 antitrypsin deficiency or drug induced)
* Cirrhosis
* Insulin dependent diabetes mellitus
* Incapable to follow the protocol instructions
* Pregnancy
* Primary or secondary liver cancer
* Severe comorbidity
* Allergic to the contrast media iohexol

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes