Liver Fibroses Clinical Trial
Verified date | March 2020 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the effects of acute alcohol challenge on the gut and liver axis.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense | Fyn |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
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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