Nutritional Interventions in Patients With Alcohol-associated Hepatitis

NCT06131177 | Not Yet Recruiting

• 1 other identifier: 13698
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Transplant free survival (30 days)

  30 days mortality (%)

  30 days

Secondary Outcomes (1)

• Transplant free survival (90 days)

  90 days

Study Arms (2)

Treatment

EXPERIMENTAL

Patients are treated with supplementary protein drink

Dietary Supplement: Nutritional supplement

SOC (standard of Care)

NO INTERVENTION

Patient are provided normal hospital diet or meal

Interventions

Nutritional supplement DIETARY_SUPPLEMENT

Protein supplement

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: November 14, 2023
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05