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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03018990
Other study ID # S-20160083
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 9, 2016
Est. completion date December 1, 2024

Study information

Verified date March 2020
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 1, 2024
Est. primary completion date November 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ethanol
1 milliliter per kilogram body weight adjusted for elevated body mass index

Locations

Country Name City State
Denmark Odense University Hospital Odense Fyn

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in concentrations of bacterial products in the liver vein Within 24 hours
Secondary changes in concentrations of bacterial products in the peripheral vein system Within 24 hours
Secondary changes in the gut microbiome Within 24 hours
Secondary changes in the liver metabolome, transcriptome and proteome Within 24 hours
Secondary changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system Within 24 hours
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