Status:
UNKNOWN
Impact of Dietary Assessment and Intervention on Outcomes in Liver Cirrhosis Patients
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
Nualtra
Conditions:
Sarcopenia
Cirrhosis, Liver
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Malnutrition and reduced muscle mass have been associated with poor outcomes in many disease conditions including severe inflammatory bowel disease, liver failure and cancers. Studies have shown that ...
Detailed Description
The investigators objectives are summarised as, Objective 1: The investigators review 25-30 new patients, and approximately 120 return patients across 4 weekly clinics. These include approximately 4...
Eligibility Criteria
Inclusion
- Confirmed cirrhosis (clinical or radiological diagnosis using liver biopsy, ultrasound/CT and/or transient elastography, Fibroscan)
- Age \> 18 years
- Child Pugh score ≥B7
- Active or recent (within the preceding 2 years) cirrhosis-related complication(s): including alcoholic hepatitis, ascites, variceal bleeding, spontaneous bacterial peritonitis, sepsis, encephalopathy, liver-related renal dysfunction, or hepatocellular carcinoma BCLC (Barcelona-Clinic Liver Cancer) stage A or B.
Exclusion
- Active cancer (non-HCC)
- Advanced stage hepatocellular carcinoma (BCLC stage C or D)
- Pregnancy
- Breastfeeding/Lactation
- Lack of capacity for informed consent
- Hepatic Encephalopathy \> Grade 2 at recruitment
- Listed for liver transplant
- Consumption of anabolic steroids for purpose of muscle development
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05259930
Start Date
March 2 2022
End Date
August 1 2025
Last Update
December 13 2023
Active Locations (1)
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1
Royal College of Surgeons in Ireland
Dublin, Ireland, D02 YN77