A Trial to Improve Quality of Life in People With Cirrhosis

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Lactulose

Criteria

Inclusion Criteria:

• Diagnosis of cirrhosis - must meet one of the following criteria:

1. liver biopsy, OR

2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR

3. 2 of the following 4 criteria:

1. Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)

2. Fibroscan liver stiffness score >13 Kilopascal (kPa)

3. Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) >2.0

4. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices

Exclusion Criteria:

• Non-English speaking

• Pregnancy (self-reported)

• Unable or unwilling to provide consent

• History of liver transplant

• Disorientation at the time of enrollment, Dementia, or Treated Memory Disorder

• History of prior lactulose use or HE within 6 months

• Metastatic solid malignancy or blood malignancy

• Hemoglobin A1C > 12 (within past year)