Nutritional Interventions in Patients With Alcohol-associated Hepatitis

Sponsor

Western University, Canada (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06131177

Collaborator

(none)

2,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Hepatitis	Dietary Supplement: Nutritional supplement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparing Nutritional Interventions in Patients With Alcohol-associated Hepatitis: a Randomized Controlled Trial

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Patients are treated with supplementary protein drink	Dietary Supplement: Nutritional supplement Protein supplement
No Intervention: SOC (standard of Care) Patient are provided normal hospital diet or meal

Arm

Intervention/Treatment

Experimental: Treatment

Patients are treated with supplementary protein drink

Dietary Supplement: Nutritional supplement

Protein supplement

No Intervention: SOC (standard of Care)

Patient are provided normal hospital diet or meal

Outcome Measures

Primary Outcome Measures

Transplant free survival (30 days) [30 days]
30 days mortality (%)

Secondary Outcome Measures

Transplant free survival (90 days) [90 days]
90 day mortality (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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

Exclusion criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Western University, Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Juan-Pablo Arab, MD, Associate Professor, Western University, Canada

ClinicalTrials.gov Identifier:

NCT06131177

Other Study ID Numbers:

13698

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 14, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis A

Hepatitis

Hepatitis, Alcoholic

Study Results

No Results Posted as of Nov 14, 2023