Alcoholic HepatitisNCT06131177
Nutritional Interventions in Patients With Alcohol-associated Hepatitis
A study testing Nutritional supplement in people with Alcoholic Hepatitis, run by Western University, Canada.
Trial summary
Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Nutritional supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years) patients admitted with acute severe AH based clinical diagnosis according to NIAAA criteria
- Excessive alcohol consumption for more than 5 years in a row or interrupted
- No more than 60 days of abstinence before the onset of jaundice
- Bilirubin levels >3 mg/dL (>50 umol/L), AST>50 IU/mL, AST/ALT ratio > 1.5
- Abstinence of other causes of liver disease
- MELD score ≥ 20
Who cannot join
- Age < 18 years
- Pregnancy or lactation.
- Allergy or intolerance to the enhanced oral intake formulation or PPN formulation.
- Expected length of stay less than 48 hours.
- Contraindications to IV fluid or PPN administration (fluid overload, suspected bacteremia).
- Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis, or Wilson's disease.
- Extrahepatic neoplasia with a life expectancy of less than 6 months.
- History of severe extrahepatic disease (e.g., chronic kidney failure requiring hemodialysis, severe heart disease (NYHA class ≥3), severe chronic lung disease (class ORO ≥3) that confers a survival of less than 6 months.
About this study
Official title: Comparing Nutritional Interventions in Patients With Alcohol-associated Hepatitis: a Randomized Controlled Trial
Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Additionally, it has been suggested that subjects with severe AH, should receive a high-protein diet, however, no specific trials have been carried out to address these questions. Thus, the investigators aim to compare nutritional interventions through a randomized controlled trial to assess if a strategy of peripheral parental nutrition (PPN) plus oral nutritional supplementation (ONS) improves outcomes in patients with severe AH. The investigators will compare standard oral intake, enhanced oral intake with IV fluid supplementation, and PPN plus ONS in patients admitted to hospital with severe AH. These results potentially will help guide practitioners on caloric benchmarks targets for patients with severe AH. This study will also assess specific risks and benefits of different nutritional interventions.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Nutritional supplement
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementDietary supplement
Protein supplement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients are treated with supplementary protein drink Receives: Dietary Supplement: Nutritional supplement |
| SOC (standard of Care) | No intervention | Patient are provided normal hospital diet or meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival (30 days)
30 days mortality (%)
Measured: 30 days
Secondary outcomes (1)
Transplant free survival (90 days)
90 day mortality (%)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan-Pablo Arab, MD, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131177
- Sponsor's protocol ID
- 13698
- Status last verified
- May 2024
- First submitted
- 16 Aug 2023
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Nutritional Interventions in Patients With Alcohol-associated Hepatitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06131177
- Acronym / sponsor ID
- 13698
- Conditions
- Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Nov 2023 (actual)
- 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.
Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Additionally, it has been suggested that subjects with severe AH, should receive a high-protein diet, however, no specific trials have been carried out to address these questions. Thus, the investigators aim to compare nutritional interventions through a randomized controlled trial to assess if a strategy of peripheral parental nutrition (PPN) plus oral nutritional supplementation (ONS) improves outcomes in patients with severe AH. The investigators will compare standard oral intake, enhanced oral intake with IV fluid supplementation, and PPN plus ONS in patients admitted to hospital with severe AH. These results potentially will help guide practitioners on caloric benchmarks targets for patients with severe AH. This study will also assess specific risks and benefits of different nutritional interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Nutritional supplementPatients are treated with supplementary protein drink |
| SOC (standard of Care) | No intervention | –Patient are provided normal hospital diet or meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (>18 years) patients admitted with acute severe AH based clinical diagnosis according to NIAAA criteria
- Excessive alcohol consumption for more than 5 years in a row or interrupted
- No more than 60 days of abstinence before the onset of jaundice
- Bilirubin levels >3 mg/dL (>50 umol/L), AST>50 IU/mL, AST/ALT ratio > 1.5
- Abstinence of other causes of liver disease
Key exclusion criteria (8 listed)
- Age < 18 years
- Pregnancy or lactation.
- Allergy or intolerance to the enhanced oral intake formulation or PPN formulation.
- Expected length of stay less than 48 hours.
- Contraindications to IV fluid or PPN administration (fluid overload, suspected bacteremia).
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 |
|---|---|---|
| Nutritional supplementProtein supplement | Dietary supplement | Treatment |
Primary outcome
Transplant free survival (30 days)
Time frame: 30 days
30 days mortality (%)
1 secondary outcome
Transplant free survival (90 days)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplement in people with Alcoholic Hepatitis, run by Western University, Canada.
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 8 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Transplant free survival (30 days) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.