A Trial to Improve Quality of Life in People With Cirrhosis

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.

Timeline

Start

2021-11-10

Primary completion

2022-11-01

Completion

2022-11-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Lactulose vs No Treatment; p = 0.6; ANCOVA NCT05061992 ↗

registry analysis (superiority test); Lactulose vs No Treatment; p = 0.2; ANCOVA NCT05061992 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lactulose	Other / unclassified	20 g	—

Indications