Status:
COMPLETED
The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Cirrhosis
Ascites
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is being completed for patients with cirrhosis, including patients with a prior history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of medically-tailored meals a...
Eligibility Criteria
Inclusion
- Diagnosis of cirrhosis will be based upon:
- liver biopsy, OR
- history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
- 2 of the following 4 criteria:
- Ultrasound, Computed tomography (CT), or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
- Fibroscan liver stiffness score \>13 kilopascals (kPa)
- Laboratory testing: aspartate aminotransferase/platelet ratio index (APRI) \>2.0
- CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
- Patients with history of \> grade 2 HE within 180 days of enrollment based on review of clinical documentation verifying the event. If a description of HE symptoms is provided in clinical documentation, but it is unclear if it meets Grade 2 criteria, the principal investigator will assess the clinical documentation and provide an HE grade.
Exclusion
- Non-English speaking
- Model for End-Stage Liver Disease (MELD) Score \> 20
- Pregnancy (self-reported)
- Unable or unwilling to provide consent
- History of liver transplant
- Current or planned admission to a nursing facility
- Serum creatinine \> 2.0 milligrams per deciliter (mg/dL) (with the exception that we will include patients with a serum creatinine \> 2.0 mg/dL if they are receiving hemodialysis)
- Disorientation at the time of enrollment
- Barcelona-Clinic Liver Cancer (BCLC) Stage D Hepatocellular Carcinoma with Child-Turcotte-Pugh (CTP) Class C
- History of eating disorder
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04675775
Start Date
January 21 2021
End Date
March 5 2023
Last Update
March 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109