A Trial to Improve Quality of Life in People With Cirrhosis

University of Michigan

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cirrhosis

Treatments

Drug: Lactulose

Study type

Interventional

Funder types

Other

Identifiers

NCT05061992

HUM00204056

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)