NCT03018990

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

January 11, 2017

Last Update Submit

March 6, 2020

Conditions

Liver FibrosesAlcohol-Induced Disorders

Outcome Measures

Primary Outcomes (1)

  • changes in concentrations of bacterial products in the liver vein

    Within 24 hours

Secondary Outcomes (4)

  • changes in concentrations of bacterial products in the peripheral vein system

    Within 24 hours

  • changes in the gut microbiome

    Within 24 hours

  • changes in the liver metabolome, transcriptome and proteome

    Within 24 hours

  • changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system

    Within 24 hours

Study Arms (3)

Alcoholic liver fibrosis

ACTIVE COMPARATOR
Other: Ethanol

Non-alcoholic steatohepatitis

ACTIVE COMPARATOR
Other: Ethanol

Healthy control

ACTIVE COMPARATOR
Other: Ethanol

Interventions

EthanolOTHER

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

Alcoholic liver fibrosisHealthy controlNon-alcoholic steatohepatitis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (2)

  • Stankevic E, Israelsen M, Juel HB, Madsen AL, Angquist L, Aldiss PSJ, Torp N, Johansen S, Hansen CD, Hansen JK, Thorhauge KH, Lindvig KP, Madsen BS, Sulek K, Legido-Quigley C, Thiele MS, Krag A, Hansen T. Binge drinking episode causes acute, specific alterations in systemic and hepatic inflammation-related markers. Liver Int. 2023 Dec;43(12):2680-2691. doi: 10.1111/liv.15692. Epub 2023 Aug 17.

    PMID: 37592403DERIVED

  • Israelsen M, Kim M, Suvitaival T, Madsen BS, Hansen CD, Torp N, Trost K, Thiele M, Hansen T, Legido-Quigley C, Krag A; MicrobLiver Consortium. Comprehensive lipidomics reveals phenotypic differences in hepatic lipid turnover in ALD and NAFLD during alcohol intoxication. JHEP Rep. 2021 Jun 29;3(5):100325. doi: 10.1016/j.jhepr.2021.100325. eCollection 2021 Oct.

    PMID: 34401690DERIVED

MeSH Terms

Conditions

Liver CirrhosisAlcohol-Induced Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Aleksander Krag, MD, PhD

    Professor, department of gastroenterology and hepatology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,clinical research assistant, PhD-student

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 12, 2017

Study Start

November 9, 2016

Primary Completion

November 12, 2018

Study Completion

December 1, 2024

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

DK(1)