A Trial to Improve Quality of Life in People With Cirrhosis

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

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 Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Drug: Lactulose

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Elliot Tapper, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Liver Disease; Hepatic Encephalopathy; Cirrhosis and portal hypertension
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: HUM00204056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No