The Role of microbial produced ethanol in etiology of non-alcoholic steatohepatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20655

Enrollment

Registered

2019-04-22

Start date

2019-04-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH

Interventions

Subjects will undergo an ultrasonography of the liver to assess hepatic steatosis and will undergo a clinical mixed meal tolerance test and get an infusion with fomepizole or saline (placebo). Only

Eligibility

Inclusion criteria

Inclusion criteria: - Diagnosis of NASH on liver biopsy taken on clinical grounds at the outpatient clinic, or healthy volunteer - 18-65 years of age - BMI > 25 kg/m2 - Subjects should be able to give informed consent

Exclusion criteria

Exclusion criteria: - Primary lipid disorder - Known genetic basis for insulin resistance or glucose intolerance - Ethanol intake > 2 U/week - Pregnancy, females who are breastfeeding - Hepatitis B and/or C - Liver cirrhosis - Auto-immune hepatitis - Wilson disease3/ alpha 1-antitripsine deficiency - Hemochromatosis - Use of drugs interacting with fomepizole (products requiring CYP2E1 for metabolizing).

Design outcomes

Primary

Measure	Time frame
To investigate whether microbial produced ethanol plays a role in the development of NASH.	—

Contacts

Public ContactStijn Meijnikman

Amsterdam UMC locatie AMC

a.s.meijnikman@amsterdamumc.nl0205661925

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)