Nutritional Interventions in Patients With Alcohol-associated Hepatitis

Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06131177
• Other study ID #: 13698
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Dietary Supplement:
• Nutritional supplement
Protein supplement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival (30 days)	30 days mortality (%)	30 days
Secondary	Transplant free survival (90 days)	90 day mortality (%)	90 days