A Trial to Improve Quality of Life in People With Cirrhosis

Study Overview
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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.

Official Title
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A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial

Conditions
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Cirrhosis

Intervention / Treatment
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* Drug: Lactulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cirrhosis - must meet one of the following 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactulose<br> | Drug: Lactulose<br>* 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.<br>* Other names: Kristalose;|
| No Intervention: No treatment<br>Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form-8 Health Survey (SF-8) at 28 Days | The SF-8 is an abbreviated version of an original 36-item health survey (SF-36). It is a generic, multipurpose, quality of life instrument, containing psychometrically based physical and mental health summary measures. The eight domains are general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. Scores from the domains are combined and range from 0 (lowest quality of living) to 100 (highest quality of living). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Animal Naming Test (ANT) | Number of unique animals named within 1 minute by the participant. Values below show the change from baseline and the results from the test taken 28 days later. | 28 days | 
| Change in Overall Sleep Quality | Overall sleep quality was measured on a 5-point Likert scale, with a range of 1 (very bad sleep quality) to 5 (very good sleep quality). | Change between baseline (day 0) and 28 days | 
| Regular Daily Activity Impairment | Single-question survey given to participants at baseline and again 28 days later. Participants ranked their daily activity impairment on a Likert scale of 0 (no impairment) to 10 (complete impairment) | 28 days | 
| Participants Who Fell | Yes or no question on whether participant had experienced at least 1 fall in the past 28 days. | 28 days | 
| Daily Bowel Movements | Results show the percentage of days in a 28-day span in which participants experienced more than 5 daily bowel movements. All participants analyzed in each arm were included in calculating the results using the following formula: (days with >5 bowel movements) / (patient-days in study) The results are presented as a single number because they are a point estimate of a population level proportion | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Encephalopathy, Liver Disease, Cirrhosis and portal hypertension