A Trial to Improve Quality of Life in People With Cirrhosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactulose

Group Type EXPERIMENTAL

Lactulose

Intervention Type DRUG

Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.

In addition, outcome measurements will be completed at baseline and day 28.

No treatment

Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lactulose

Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.

In addition, outcome measurements will be completed at baseline and day 28.

Intervention Type DRUG

Other Intervention Names

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Kristalose

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No