Individual nutrition support for patients with hepatitis B-related liver failure

Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk: a Randomized Controlled Trail

This study is testing if personalized nutrition support can help patients with liver failure from hepatitis B stay healthier and avoid serious complications compared to standard hospital nutrition.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 20 Years to 60 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06128421 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of personalized nutrition support for patients suffering from hepatitis B virus-related acute-on-chronic liver failure who are at risk of malnutrition. The study will enroll 60 patients, dividing them into two groups: one receiving tailored nutritional therapy aimed at meeting specific caloric and protein targets, and the other receiving standard hospital nutrition based on appetite. Participants will be monitored daily to assess their nutritional intake and therapy adjustments will be made if targets are not met within the first three days. The goal is to prevent mortality, morbidity, and functional decline in this vulnerable patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 60 with chronic hepatitis B infection and a nutritional risk score indicating undernutrition.

Not a fit: Patients with other active liver diseases, malignancies, or severe complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the nutritional status and overall health outcomes for patients with hepatitis B-related liver failure.

How similar studies have performed: While similar approaches have been explored, this specific individualized nutritional strategy in the context of HBV-related ACLF is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age from 20 to 60 years old;
2. Clinical diagnosis of chronic hepatitis b virus infection(positive hepatitis b surface antigen or positive hepatitis b virus DNA \>0.5 year
3. serum total bilirubin level ≥12 mg/dl
4. prothrombin time international ratio ≥1.5
5. NRS≥ 3points
6. COSSH-ACLF IIs \<8.4 points

Exclusion Criteria:

1. Other active liver disease;
2. Hepatocellular carcinoma or other malignancy, HIV, Chronic kidney disease(CKD), diabetes, thyroid disease, cardiopulmonary disease, neuromuscular diseases, serious psychiatric disease;
3. Acute cholecystitis, acute pancreatitis, biliary obstruction, short bowel syndrome, intestinal obstruction, inflammatory bowel disease;
4. Severe complications or other organ failure including sever infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal failure(AGI III-IV);
5. Pregnancy, BMI\<18.5 or BMI ≥28，organ transplantation, bed-ridden;
6. Unable to ingest oral nutrition, contraindication against parenteral nutrition
7. Admitted with enteral or parenteral nutrition in the last week
8. expected hospital length of stay\<3 days，.expected residence in Guangdong Province length of live\< 90 days

Where this trial is running

Guangzhou, Guangdong

• Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Li Zhipeng

Conditions: Malnutrition, Hepatitis B,Chronic, Acute-On-Chronic Liver Failure, Nutrition Support