Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06131177
Other study ID # 13698
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04066179 - Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients. N/A
Completed NCT03732586 - Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00962442 - N-Acetylcysteine in Severe Acute Alcoholic Hepatitis Phase 3
Not yet recruiting NCT06307522 - MRG-001 in Patients With Alcoholic Hepatitis Phase 2
Recruiting NCT05018481 - HA35 Moderate Alcoholic Hepatitis (AH) Study Early Phase 1
Completed NCT04544020 - Changes in gUt micRobiota After Enteral Feeding (in Alcoholic Hepatitis)
Recruiting NCT04088370 - Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
Completed NCT04235855 - EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication? N/A
Active, not recruiting NCT02344680 - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed NCT00851981 - Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease Phase 2
Completed NCT04084522 - Effect of Saturated Fat (Desi Ghee) on Gut-Liver Axis in Alcoholic Hepatitis N/A
Completed NCT05840640 - Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis Phase 4
Recruiting NCT03069300 - N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis Phase 3
Terminated NCT02039219 - Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH) Phase 2
Completed NCT01245257 - Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis N/A
Completed NCT02019056 - Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis Phase 2
Completed NCT00388323 - Adipose Tissue Involvement in Alcohol-induced Liver Inflammation in Human N/A
Recruiting NCT03845205 - Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH N/A
Recruiting NCT03703674 - GCSF in Alcoholic Hepatitis Phase 4