CompletedPhase 2/3

A Trial to Improve Quality of Life in People With Cirrhosis

United States56 participantsStarted 2021-11-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 Kilopascal (kPa)
✓. Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) \>2.0
✓. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices

What they're measuring

Short Form-8 Health Survey (SF-8) at 28 Days

Timeframe: 28 days

Trial details

NCT IDNCT05061992

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-01

Results submitted2023-10-18

View on ClinicalTrials.gov More Cirrhosis trials