Liver FibrosesNCT03018990
Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
A study testing Ethanol in people with Liver Fibroses and Alcohol-Induced Disorders, run by Odense University Hospital at 1 site in Denmark.
Trial summary
To investigate the effects of acute alcohol challenge on the gut and liver axis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibroses, Alcohol-Induced Disorders
- What is being tested?
- Ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Nov 2016to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Incapable to follow the protocol instructions
- Pregnancy
- Primary or secondary liver cancer
- Severe comorbidity
- Allergic to the contrast media iohexol
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effects of acute alcohol challenge on the gut and liver axis.
Read the detailed 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.
- Conditions
- Liver Fibroses, Alcohol-Induced Disorders
- Being tested
- Ethanol
- Medical subject headings
- Liver Cirrhosis, Alcohol-Induced Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolOther
1 milliliter per kilogram body weight adjusted for elevated body mass index
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic liver fibrosis | Active comparator | Not described Receives: Other: Ethanol |
| Non-alcoholic steatohepatitis | Active comparator | Not described Receives: Other: Ethanol |
| Healthy control | Active comparator | Not described Receives: Other: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in concentrations of bacterial products in the liver vein
Measured: Within 24 hours
Secondary outcomes (4)
changes in concentrations of bacterial products in the peripheral vein system
Measured: Within 24 hours
changes in the gut microbiome
Measured: Within 24 hours
changes in the liver metabolome, transcriptome and proteome
Measured: Within 24 hours
changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start9 Nov 2016
- Primary completion12 Nov 2018
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Israelsen, Odense University Hospital
- Investigators
- Aleksander Krag, MD, PhD, Principal investigator, Professor, department of gastroenterology and hepatology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018990
- Sponsor's protocol ID
- S-20160083
- Status last verified
- Mar 2020
- First submitted
- 11 Jan 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37592403Israelsen 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.
PubMed 34401690
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
- ClinicalTrials.gov ID
- NCT03018990
- Acronym / sponsor ID
- S-20160083
- Conditions
- Liver Fibroses, Alcohol-Induced Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effects of acute alcohol challenge on the gut and liver axis.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alcoholic liver fibrosis | Active comparator | Other: Ethanol |
| Non-alcoholic steatohepatitis | Active comparator | Other: Ethanol |
| Healthy control | Active comparator | Other: Ethanol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanol1 milliliter per kilogram body weight adjusted for elevated body mass index | Other | Alcoholic liver fibrosis, Healthy control, Non-alcoholic steatohepatitis |
Primary outcome
changes in concentrations of bacterial products in the liver vein
Time frame: Within 24 hours
4 secondary outcomes
changes in concentrations of bacterial products in the peripheral vein system
Time frame: Within 24 hours
changes in the gut microbiome
Time frame: Within 24 hours
changes in the liver metabolome, transcriptome and proteome
Time frame: Within 24 hours
changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system
Time frame: Within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 37592403Stankevic 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.
- Derived from this study: PubMed 34401690Israelsen 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.
Related trials for Liver Fibroses
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksander Krag, MD, PhD principal investigator
Professor, department of gastroenterology and hepatology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol in people with Liver Fibroses and Alcohol-Induced Disorders, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in concentrations of bacterial products in the liver vein (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03018990, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.