Status:
ENROLLING_BY_INVITATION
Oral Branched-chain Amino Acid Supplementation for Decompensated Cirrhotic Patients
Lead Sponsor:
Mahidol University
Conditions:
Decompensated Cirrhosis and Ascites
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/...
Detailed Description
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/...
Eligibility Criteria
Inclusion
- Cirrhotic patients of all etiology with aged of 18-85 years
- Clinically detectable ascites
- Serum albumin \< 3 g/dL
Exclusion
- Patients with hepatocellular carcinoma outside the Milan criteria.
- Patients with history of gastrointestinal bleeding and spontaneous bacterial peritonitis (SBP) within the last 3 months.
- Patients with acute on chronic liver failure (ACLF).
- Patients with uncontrollable chronic comorbidities, including chronic heart failure in NYHA stages 3-4, end stage kidney disease requiring dialysis, and chronic obstructive pulmonary disease Gold D.
- 5 .Patients who have undergone liver or kidney transplant. 6. Patients with Human Immunodeficiency Virus (HIV). 7. Pregnant or lactating patients. 8. Patients who have undergone large volume paracentesis (\>5 liters) with intravenous albumin administration on the day of study enrollment. 9. Patients with a history of above-knee amputation surgery. 10. Patients with a history of receiving intravenous albumin administration every 1-2 weeks within the last one month.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06121479
Start Date
November 13 2023
End Date
December 31 2025
Last Update
September 29 2025
Active Locations (1)
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1
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Bangkok, Bangkok, Thailand, 10700