A Trial to Improve Quality of Life in People With Cirrhosis

Phase 3CompletedNCT05061992

University of Michigan56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cirrhosis

Interventions

LactuloseDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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).

Time frame: 28 days

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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)

Time frame: 28 days

Participants Who Fell

Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.

Time frame: 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

Data from ClinicalTrials.gov

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